CN105396207B - Mask system - Google Patents

Mask system Download PDF

Info

Publication number
CN105396207B
CN105396207B CN201510757297.0A CN201510757297A CN105396207B CN 105396207 B CN105396207 B CN 105396207B CN 201510757297 A CN201510757297 A CN 201510757297A CN 105396207 B CN105396207 B CN 105396207B
Authority
CN
China
Prior art keywords
mouth
nares
patient
mask system
seal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CN201510757297.0A
Other languages
Chinese (zh)
Other versions
CN105396207A (en
Inventor
贾斯廷·约翰·福尔米卡
乔斯·伊格纳西奥·罗马尼奥利
菲利普·罗德尼·夸克
乔尔·爱德华·吉布森
戴维·安东尼·皮德科克
克里斯托弗·斯科特·斯基珀
斯蒂芬·格雷
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Reisman Private Ltd
Original Assignee
Reisman Private Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Reisman Private Ltd filed Critical Reisman Private Ltd
Publication of CN105396207A publication Critical patent/CN105396207A/en
Application granted granted Critical
Publication of CN105396207B publication Critical patent/CN105396207B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A61M16/0611—Means for improving the adaptation of the mask to the patient with a gusset portion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A61M16/0616—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure
    • A61M16/0622—Means for improving the adaptation of the mask to the patient with face sealing means comprising a flap or membrane projecting inwards, such that sealing increases with increasing inhalation gas pressure having an underlying cushion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0683—Holding devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0875—Connecting tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A61M16/0633—Means for improving the adaptation of the mask to the patient with forehead support
    • A61M16/0644—Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position
    • A61M16/0655—Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position in the form of a linear or curvilinear slide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0825—Joints or connectors with ball-sockets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0225—Carbon oxides, e.g. Carbon dioxide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/06—Packaging for specific medical equipment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0618—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0625—Mouth

Landscapes

  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Otolaryngology (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)

Abstract

A mask system for delivering respiratory therapy to a patient includes a nares portion, a mouth portion, and an inlet conduit connected to at least one of the nares portion and the mouth portion to deliver pressurized breathable gas. The mask system is adapted to selectively use the nares portion and/or the mouth portion in a first mode using both the nares portion and the mouth portion and in a second mode using the nares portion without the mouth portion.

Description

Mask system
The application is a divisional application of an invention patent application with the application date of 2011, 9 and 30, the application number of 201180047592.7 and the name of a mask system.
Cross reference to applications
This application claims the benefit of U.S. applications 61/388,357, 61/443,623, 61/457,981 and 61/528,524, filed on 30/2010, 16/2011, 7/2011, 27/2011 and 29/2011, respectively, each of which is incorporated herein by reference in its entirety.
Technical Field
The present invention relates to a mask system for non-invasive positive pressure ventilation (NPPV) and Continuous Positive Airway Pressure (CPAP) treatment of Sleep Disordered Breathing (SDB) conditions such as Obstructive Sleep Apnea (OSA).
Background
The treatment of Sleep Disordered Breathing (SDB) such as Obstructive Sleep Apnea (OSA) by a Continuous Positive Airway Pressure (CPAP) flow generator (flow generator) system involves: air (or other breathable gas) pressurized above atmospheric pressure is continuously delivered to the airway of a human or other mammalian patient via a conduit or mask. Typically, the mask fits over or into the mouth and/or nose of the patient. The pressurized air flows to the mask and to the airway of the patient via the nose and/or mouth. The pressurized air is delivered to the mask through a conduit connected to the CPAP device and the mask.
The mask should be comfortable and non-interfering so that patients can tolerate their treatment and remain in use. Some patients may prefer a pillow or fork type mask (as is known in the art), or a nasal or full face mask. Some patients may prefer to use one or a combination of the masks interchangeably. However, this would require the purchase of a number of different mask systems, which would be expensive and/or not covered by insurance.
Additionally, masks including oronasal masks typically include a rigid frame. The patient may find such a mask uncomfortable. The frame may also cause the sealing portion of the mask to be disengaged from the patient's face if the frame is contacted or forced by clothing, pillows, etc. on the bed.
Disclosure of Invention
One aspect of the present invention relates to a mask system that can be used as a nose mask only or an oronasal mask.
Another aspect of the invention relates to an oronasal mask consisting essentially of a flexible member.
Another aspect of the present invention relates to an oronasal mask that is secured at a nasal seal portion separate from a mouth seal portion.
Another aspect of the invention relates to an oronasal mask having at least a first headgear attachment element on a nasal portion of the mask and at least a second headgear attachment element on a mouth portion of the mask.
Another aspect of the invention relates to a modular mask system adapted for use in a nares-only configuration or in a nares and mouth configuration.
Another aspect of the invention relates to a modular mask system adapted for use in a nares-only configuration, a mouth-only configuration, or both.
In one form of the invention, the mask system is provided with a nares portion and a mouth portion that can be used depending on the patient's choice of nares portion and mouth portion or nares portion alone. When used with a nares portion, the mouth portion may be used to deliver respiratory therapy to the mouth of a patient, or the mouth portion may be used as a mouth seal.
In one form of the invention, the mask system is provided with a nares portion and a mouth portion that can be used depending on the patient's choice of nares portion and mouth portion, nares portion only, or mouth portion only.
In one form of the invention, a mask system is provided with a nares portion and a mouth portion, wherein the nares portion includes a nares sealing portion adapted to form a seal with a patient's nares, wherein the nares sealing portion is configured to extend or curve outwardly from a support wall defining an air path into the nares sealing portion.
Another aspect of the invention relates to a mask system that includes a nares portion and a mouth portion, and the mouth portion is adapted for use in a first configuration in which at least a portion of pressurized breathable gas is delivered to a patient's mouth and a second configuration in which the mouth portion acts as a mouth seal that prevents any pressurized breathable gas from being delivered to the patient's mouth.
Another aspect of the invention relates to a method of providing a mask system kit for delivering respiratory therapy to a patient, wherein the nares portion and the mouth portion can be used in accordance with a patient's selection of nares portion and mouth portion, nares portion only, or mouth portion only.
Another aspect of the invention relates to a method of providing a mask system kit for delivering respiratory therapy to a patient, wherein the nares and mouth portions can be used in accordance with a patient's selection of the nares and mouth portions, either only the nares or only the mouth portion, wherein when both the nares and mouth portions are used, either the nares and mouth portions may be used to deliver pressurized air to the patient's nares and mouth, respectively, or one of the nares and mouth portions may be used to deliver pressurized air to the patient's nares or mouth while the other of the nares and mouth portions functions as a nares seal or mouth seal.
Another aspect of the invention relates to a method of transitioning a mask system having a nares portion and a mouth portion between a first mode in which the mask system is usable with the nares portion and the mouth portion and a second mode in which the mask system is usable only with the nares portion.
Another aspect of the invention relates to a kit for providing a nares-only portion for delivering respiratory therapy to a patient's nares, the nares portion adapted to function with a mouth portion.
Another aspect of the invention relates to a kit for providing a mouth portion for delivering respiratory therapy to a mouth of a patient, the mouth portion adapted to function with a nares portion.
Another aspect of the invention relates to a method comprising: providing respiratory therapy to one of both the patient's nares and mouth, only the patient's nares, or only the patient's mouth; and periodically changing the respiratory therapy to the other of the patient's nares and mouth, to only the patient's nares, or to both the patient's nares and mouth.
Another aspect of the invention relates to a method of respiratory therapy treatment in which a first mask having a first footprint is applied to a patient for a period of time, the first mask is then removed, and a second mask having a second footprint different from the first footprint is applied to the patient for a second period of time.
Another aspect of the invention relates to a mouth portion for delivering respiratory therapy to a patient's mouth, the mouth portion including a docking station adapted to receive a nares portion, wherein the nares portion is capable of functioning as a nares-only device for delivering pressurized gas to the patient's nares.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a nares portion adapted to form a seal with a patient's nares; a mouth portion comprising a mouth chamber and a mouth seal portion adapted to form a seal with a patient's mouth, the mouth chamber comprising an opening adapted to selectively receive pressurized breathable gas; an input conduit connected with at least one of the nares portion and the mouth portion to deliver pressurized breathable gas, wherein the mask system is adapted to selectively use the nares portion and/or the mouth portion in a first mode using both the nares portion and the mouth portion and in a second mode using the nares portion without the mouth portion.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a nares portion adapted to form a seal with a patient's nares; a mouth portion comprising a mouth chamber and a mouth seal portion adapted to form a seal with a patient's mouth; an input conduit connected with at least one of the nares portion and the mouth portion for delivering pressurized breathable gas to the patient, wherein the nares portion and the mouth portion are adapted to be connected to one another and the mouth portion is adapted to selectively function in a first configuration in which at least a portion of the pressurized breathable gas is delivered to the patient's mouth and a second configuration in which the mouth portion acts as a mouth seal that prevents any pressurized breathable gas from being delivered to the patient's mouth.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a sealing portion including a nares sealing portion adapted to form a seal with a patient's nares, the nares sealing portion being configured to extend or curve outwardly from a support wall defining an air path into the nares sealing portion, and a mouth sealing portion adapted to form a seal with the patient's mouth, the sealing portion being adapted to connect with at least one input conduit to receive a supply of pressurized breathable gas; and headgear for holding the seal assembly in place on the patient's head.
Another aspect of the invention relates to a method of providing a mask system kit for delivering respiratory therapy to a patient, the method comprising: providing a nares portion adapted to form a seal with a patient's nares; providing a mouth portion comprising a mouth chamber and a mouth seal portion adapted to form a seal with a patient's mouth, the mouth chamber comprising an opening adapted to selectively receive pressurized breathable gas; and providing an input conduit connectable with at least one of the nares portion and the mouth chamber to deliver pressurized breathable gas, wherein, depending on a patient's selection, the mask system is adapted to selectively use the nares portion and/or the mouth portion in at least a first mode to provide respiratory therapy to the nares of the patient using the nares portion and the mouth portion, wherein the mouth portion is structured to provide respiratory therapy to the patient's mouth or to seal the mouth portion, and a second mode in which respiratory therapy is provided to the patient's nares using the nares portion without the mouth portion acting as a seal or being used to deliver respiratory therapy.
Another aspect of the invention relates to a method of transitioning a mask system for delivering respiratory therapy to a patient between a first mode and a second mode, the method comprising: providing a nares portion adapted to form a seal with a patient's nares; providing a mouth portion comprising a mouth chamber and a mouth seal portion adapted to form a seal with a patient's mouth, the mouth chamber comprising an opening adapted to selectively receive pressurized breathable gas; assembling the mask system in a first mode of providing respiratory therapy to the patient's nares using the nares portion and the mouth portion, providing respiratory therapy to the patient's mouth using the mouth portion, or using the mouth portion as a mouth seal; and switching the mask system in a second mode in which respiratory therapy is provided to the patient's nares using the nares portion without using the mouth portion.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a mouth portion comprising a mouth chamber and a mouth seal portion adapted to form a seal with a patient's mouth, the mouth chamber comprising an opening adapted to selectively receive pressurized breathable gas; and a nares portion interface formed on the mouth portion, the nares portion interface adapted to receive a nares portion, wherein the nares portion is capable of functioning as a nares-only device for delivering pressurized gas to a patient's nares.
Another aspect of the invention relates to a medical enclosure including a kit for converting a CPAP device including a nares only portion to a CPAP device having a nares portion and a mouth portion, the medical enclosure comprising: a mouth portion comprising a mouth chamber and a mouth seal portion adapted to form a seal with a patient's mouth, the mouth chamber comprising an opening adapted to selectively receive pressurized breathable gas; a vent plug adapted to plug a hole in the nostril only portion; and a headband adapted to secure at least the mouth portion to the head of a patient.
Another aspect of the invention relates to a system kit adapted to convert a nares-only device for delivering respiratory therapy to a patient into a nares and mouth device for delivering respiratory therapy to a patient, the system kit comprising: a mouth portion comprising a mouth chamber and a mouth seal portion adapted to form a seal with a patient's mouth, the mouth chamber including an opening adapted to selectively receive pressurized breathable gas, the mouth portion adapted to function with a nares-only device as a nares and mouth-type device; a plug adapted to connect with an opening in a mouth chamber or an opening in a nares-only device; and a headgear adapted to secure at least the mouth portion to the patient's head.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a nares portion adapted to form a seal with a patient's nares; a mouth portion comprising a mouth chamber and a mouth seal portion adapted to form a seal with a patient's mouth; and a double elbow, for example, having one branch connected to the nares portion and another branch connected to the mouth portion, to deliver pressurized breathable gas to the nares portion and the mouth portion.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a nares portion adapted to form a seal with a nares of a patient; a mouth portion comprising a mouth chamber and a mouth seal portion adapted to form a seal with a patient's mouth; and a cover sheet extending from the mouth portion to cover the nares portion and/or the patient's nares in use.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a nares portion comprising a nares sealing portion adapted to form a seal with a nares of a patient; a mouth portion including a mouth seal portion adapted to form a seal with a patient's mouth, the mouth seal portion being oriented generally horizontally and the nares seal portion being oriented generally vertically.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a nares portion comprising a nares sealing portion and a nares support portion, the nares sealing portion adapted to form a seal with a patient's nares; a mouth portion comprising a mouth seal portion adapted to form a seal with a patient's mouth, the nares support portion being a semi-rigid material and the nares seal portion being a flexible material.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a nares portion comprising a nares sealing portion and a nares support portion, the nares sealing portion adapted to form a seal with a patient's nares; a mouth portion comprising a mouth seal portion adapted to form a seal with a patient's mouth, the mouth portion and/or the nares portion comprising a magnet that holds the mouth portion and/or the nares portion in place.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a nares portion adapted to form a seal with a nares of a patient; a mouth portion adapted to form a seal with a mouth of a patient; and a foam portion adapted to clip onto at least one of the nares portion and the mouth portion to form a seal between the mask system and the patient.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a nares portion comprising a nares sealing portion and a nares support portion, the nares sealing portion adapted to form a seal with a patient's nares; a mouth portion including a mouth seal portion adapted to form a seal with a patient's mouth; and a connecting ring adapted to connect the mouth portion with the nares portion, the connecting ring having a first channel adapted to receive the mouth portion and a second channel adapted to receive the nares portion.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a nares portion comprising a nares sealing portion and a nares support portion, the nares sealing portion adapted to form a seal with a patient's nares; a mouth portion including a mouth seal portion adapted to form a seal with a patient's mouth, wherein the nares seal portion has a recess adapted to form an interference fit with the mouth portion.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a nares portion comprising a nares sealing portion and a nares support portion, the nares sealing portion adapted to form a seal with a patient's nares; a mouth portion including a mouth seal portion adapted to form a seal with a patient's mouth; upper headgear adapted to connect with the nares portion, the upper headgear including a rear strap adapted to wrap around a rear portion of the patient's head; and a lower headgear adapted to be connected with the mouth portion, the lower headgear having a loop adapted to receive a rear strap of the upper headgear.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a nares portion comprising a nares sealing portion adapted to form a seal with a nares of a patient; an elbow connected to the nares portion for delivering pressurized gas, the elbow including a ledge portion; a mouth portion including a mouth seal portion adapted to form a seal with a patient's mouth, the mouth portion including an aperture selectively connectable with the lug portion of the elbow to connect the mouth portion with the nares portion.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a nares portion comprising a nares sealing portion adapted to form a seal with a nares of a patient; a mouth portion including a mouth seal portion adapted to form a seal with a patient's mouth, the mouth seal portion including a cushion having a pocket or lower durometer region shaped and adapted to receive a nares portion.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a nares portion comprising a nares sealing portion and a nares support portion, the nares sealing portion adapted to form a seal with a patient's nares; a mouth portion including a mouth seal portion adapted to form a seal with a patient's mouth, the mouth portion including a cushion and a cushion bandage portion adapted to be connected to the cushion, the cushion having a connecting portion with an aperture adapted to receive a loop connecting the nares portion to the mouth portion.
Another aspect of the invention relates to a mask system for delivering respiratory therapy to a patient, the mask system comprising: a mouth portion including a mouth seal portion adapted to form a seal with a patient's mouth, the mouth seal portion not including a recess.
Other aspects, features and advantages of the present invention will become apparent from the following detailed description when taken in conjunction with the accompanying drawings, which form a part hereof, and which illustrate, by way of example, the principles and principles of the invention.
Drawings
The accompanying drawings are included to provide a further understanding of the various examples of the invention. In these drawings:
1-1 depict a front view of a mask system on a model patient's head in a nostril only mode according to an embodiment of the present invention;
1-2 depict front views of a mask system in a nares and mouth mode on a model patient's head, in accordance with an embodiment of the present invention;
1-3 depict front views of a mask system in a nares and mouth mode on a model patient's head, in accordance with an embodiment of the present invention;
1-4 depict front views of a mask system on a model patient's head in a mouth-only mode according to an embodiment of the present invention;
1-5 depict exploded front views of a mask system according to an embodiment of the present invention, showing how the nares portion connects to the mouth portion;
FIG. 2 depicts a front view of the mask system of FIGS. 1-1 to 1-5 without an elbow connector, according to an embodiment of the invention;
FIG. 3 depicts a rear view of the mask system of FIGS. 1-1 to 1-5, according to an embodiment of the present invention;
fig. 4 depicts a rear isometric view of the mask system of fig. 1-1 to 1-5, in accordance with an embodiment of the present invention;
FIG. 5-1 depicts a front isometric view of a mask system according to another embodiment of the invention on a model patient's head;
fig. 5-2 depicts a front isometric view of the mask system of fig. 501 in a nostril only mode on a model patient's head;
FIG. 6 depicts a side view of the mask system of FIG. 5 in use, in accordance with an embodiment of the present invention;
FIG. 7 depicts a rear isometric view of a headgear for the mask system of FIG. 5-1, according to an embodiment of the present invention;
FIG. 8 depicts a front isometric view of the mask system of FIG. 5-1 without an elbow connector according to an embodiment of the invention;
FIG. 9 depicts a front view of the mask system of FIG. 5-1 without an elbow connector, according to an embodiment of the invention;
FIG. 10 depicts a top view of the mask system of FIG. 5-1 without the nares portion, in accordance with an embodiment of the present invention;
fig. 11 depicts a rear isometric view of the mask system of fig. 5-1, in accordance with an embodiment of the present invention;
FIG. 12 depicts a rear view of the mask system of FIG. 5-1, in accordance with an embodiment of the present invention;
FIG. 13 depicts a front view of a portion of the mask system of FIG. 5-1 without a nares portion and without an elbow connector and including headgear, according to an embodiment of the invention;
FIG. 14 depicts a front view of a mask system on a model patient's head according to another embodiment of the present invention;
FIG. 15 depicts a side view of the mask system of FIG. 14 on a model patient's head, in accordance with an embodiment of the present invention;
FIG. 16 depicts a rear view of a mask system with a decoupling portion (decoupling portion) and a connecting portion removed, according to another embodiment of the present invention;
fig. 17 depicts a front isometric view of the mask system of fig. 16, in accordance with an embodiment of the present invention;
fig. 18 depicts a front isometric view of the mask system of fig. 16, in accordance with an embodiment of the present invention;
FIG. 19 depicts a rear isometric view of a nares portion that may be used with a mask system in accordance with an embodiment of the present invention;
figure 20 depicts a front isometric view of the nares portion of figure 19, in accordance with an embodiment of the present invention;
figure 21 depicts a front isometric view of a mask system on a model patient's head in a nostril only mode according to another embodiment of the present invention;
fig. 22 depicts a front isometric view of the mask system of fig. 21 in a nostril and mouth configuration on a model patient's head, in accordance with an embodiment of the invention;
fig. 23 depicts a front isometric view of a mask system according to another embodiment of the invention on a model patient's head;
FIG. 24 depicts a side view of a mask system on a model patient's head according to another embodiment of the present invention;
FIG. 25 depicts a side view of a mask system on a model patient's head according to another embodiment of the present invention;
fig. 26 depicts a schematic cross-sectional view of a modular mask system on a model patient's head according to an embodiment of the invention;
FIG. 27 depicts a schematic cross-sectional view of an integrated mask system on a model patient's head, in accordance with an embodiment of the invention;
FIG. 28 depicts a schematic cross-sectional view of an integrated mask system on a model patient's head, in accordance with an embodiment of the invention;
fig. 29-1 depicts a schematic cross-sectional view of a modular mask system on a model patient's head according to an embodiment of the invention;
FIG. 29-2 depicts a schematic top view of the mouth seal portion of the mask system of FIG. 29-1, in accordance with an embodiment of the invention;
29-3 depict a schematic cross-sectional view of a modular mask system on a model patient's head according to an embodiment of the present invention;
FIG. 30-1 depicts a schematic cross-sectional view of a modular mask on a model patient's head in accordance with an embodiment of the invention;
fig. 30-2 depicts a schematic cross-sectional view of a modular mask system on a model patient's head according to an embodiment of the invention;
FIG. 31 depicts a cross-sectional view of an integrated mask system on a model patient's head, in accordance with an embodiment of the present invention;
FIGS. 32(a) - (k) are schematic illustrations of the flow of pressurized gas through various configurations of a mask system according to an embodiment of the present invention;
figure 33 depicts a schematic view of a nares and mouthpiece according to an embodiment of the invention;
FIG. 34 depicts a schematic view of a modular mask system on a model patient's head, according to an embodiment of the present invention;
figure 35 depicts a front view of a nares sealing portion, in accordance with an embodiment of the present invention;
figure 36 depicts a front perspective view of the nares sealing portion of figure 35, in accordance with an embodiment of the present invention;
FIG. 37 depicts a prior art nasal only CPAP device on a model patient's head;
figure 38 depicts a retrofit kit for converting the nares-only CPAP device of figure 37 into a nares and mouth CPAP device, in accordance with an embodiment of the present invention;
FIG. 39 depicts a retrofit kit for converting the nares-only CPAP device of FIG. 37 to a nares and mouth CPAP device, in accordance with an embodiment of the present invention;
FIG. 40 depicts a prior art nasal only CPAP device;
FIG. 41 depicts a retrofit kit for converting the nares-only CPAP device of FIG. 40 to the nares and mouth CPAP device shown on a model patient's head in accordance with an embodiment of the present invention;
fig. 42 depicts a schematic cross-sectional view of a modular mask system on a model patient's head according to an embodiment of the invention;
fig. 43 depicts a schematic cross-sectional view of a modular mask system on a model patient's head according to an embodiment of the invention;
fig. 44 depicts a schematic cross-sectional view of a modular mask system on a model patient's head according to an embodiment of the present invention;
figure 44A is a cross-sectional view of a nostril portion according to an embodiment of the present invention;
figure 44B is a cross-sectional view of a nostril portion according to an embodiment of the present invention;
fig. 45 depicts a schematic cross-sectional view of a modular mask system on a model patient's head according to an embodiment of the invention;
fig. 46 depicts a schematic cross-sectional view of a modular mask system on a model patient's head according to an embodiment of the invention;
fig. 47 depicts a schematic cross-sectional view of a modular mask system on a model patient's head, in accordance with an embodiment of the invention;
fig. 48 depicts a schematic partial cross-sectional view of a modular mask system according to an embodiment of the invention;
FIG. 49 is an exploded view of a modular mask system on a model patient's head according to an embodiment of the present invention;
FIG. 50 depicts a schematic cross-sectional view of an integrated (or modular) mask system on a model patient's head, in accordance with an embodiment of the invention;
FIG. 51 depicts a perspective view of the integrated (or modular) mask system of FIG. 50 on a model patient's head;
FIG. 52 depicts a side view of the integrated (or modular) mask system of FIG. 51;
fig. 53 depicts a schematic cross-sectional view of a modular mask system on a model patient's head according to an embodiment of the invention;
fig. 54 depicts a schematic cross-sectional view of a modular mask system on a model patient's head, in accordance with an embodiment of the invention;
FIG. 55 depicts a rear view of the nose portion of the mask system according to an embodiment of the invention;
FIG. 55A is a cross-sectional view through line 55A-55A of FIG. 55;
FIG. 56 depicts a rear view of the nose portion of the mask system according to an embodiment of the invention;
FIG. 56A is a cross-sectional view through line 56A-56A of FIG. 56;
fig. 57 depicts a schematic cross-sectional view of a modular mask system on a model patient's head according to an embodiment of the invention;
FIG. 58 depicts a side view of the integrated or modular mask system on a model patient's head, according to an embodiment of the present invention;
FIG. 59 depicts a perspective view of an integrated or modular mask system on a model patient's head, according to an embodiment of the present invention;
fig. 60 depicts a rear view of a modular mask system according to an embodiment of the invention;
fig. 61 depicts a schematic cross-sectional view of a modular mask system on a model patient's head according to an embodiment of the invention;
fig. 62 depicts a schematic cross-sectional view of a modular mask system on a model patient's head, in accordance with an embodiment of the invention;
fig. 63 depicts an exploded view of a modular mask system according to an embodiment of the present invention;
fig. 64 depicts a schematic cross-sectional view of a modular mask system on a model patient's head in accordance with an embodiment of the invention;
fig. 65 depicts a schematic cross-sectional view of a modular mask system on a model patient's head, in accordance with an embodiment of the invention;
fig. 66 depicts an exploded view of a modular mask system according to an embodiment of the present invention;
fig. 67 depicts an exploded view of a modular mask system according to an embodiment of the present invention;
fig. 68 depicts a perspective view of a modular mask system according to an embodiment of the present invention;
fig. 69 depicts a front view of the modular mask system of fig. 68;
fig. 70 depicts a top view of the modular mask system of fig. 68;
fig. 71 depicts a bottom view of the modular mask system of fig. 68;
fig. 72 depicts a side view of the modular mask system of fig. 68;
FIG. 73 depicts a cross-sectional view along line 73-73 in FIG. 69;
fig. 74 depicts a perspective view of the nares portion of the mask system of fig. 68;
fig. 75 depicts a perspective view of a mouth portion of the mask system of fig. 68;
fig. 76 depicts a perspective view of the cushion portion of the mask system of fig. 68;
fig. 77 depicts a front view of the cushion portion of the mask system of fig. 68;
fig. 78 depicts a top view of the cushion portion of the mask system of fig. 68;
fig. 79 depicts a bottom view of the cushion portion of the mask system of fig. 68;
FIG. 80 depicts a cross-sectional view along line 80-80 of FIG. 77;
FIG. 81 depicts a cross-sectional view along line 81-81 of FIG. 77;
FIG. 82 depicts a cross-sectional view along line 82-82 of FIG. 77;
FIG. 83 depicts a cross-sectional view along line 83-83 of FIG. 77;
FIG. 84 depicts a cross-sectional view along line 84-84 of FIG. 77;
FIG. 85 depicts a cross-sectional view along line 85-85 of FIG. 77;
fig. 86 depicts a rear view of the cushion portion of the mask system of fig. 68;
fig. 87 depicts a right side view of the cushion portion of the mask system of fig. 68;
fig. 88 depicts a left side view of the cushion portion of the mask system of fig. 68;
fig. 89 depicts a perspective view of the cushion portion of the mask system of fig. 68;
fig. 90, 91A and 91B illustrate a headgear system according to a sample of the prior art that is capable of transitioning between two-point support and four-point support;
fig. 92A to 92E and 93A to 93I show a mouth cushion according to a modification of the present invention;
fig. 94-102 illustrate an exemplary cushion-bandage connection in accordance with the present invention;
figure 103 illustrates an example lip seal in accordance with this invention;
fig. 104 is an exploded assembly view of a mask system according to an embodiment of the present invention;
FIG. 105 is a rear view of the mask system of FIG. 104 in an assembled state;
FIG. 106 is a top view of the mask system of FIG. 104 in an assembled state;
fig. 107 is a bottom view of the mask system of fig. 104 in an assembled state;
FIG. 108 is a left side view of the mask system of FIG. 104 in an assembled state;
FIG. 109 is a cross-sectional view taken along line 109 and 109 of FIG. 105;
FIG. 110 is a cross-sectional view taken along line 110-110 of FIG. 105;
FIG. 111 is a detail view of a portion of FIG. 110;
fig. 112 is a rear isometric view of a mouth cushion of the mask system of fig. 104;
fig. 113 is a front isometric view of a mouth cushion of the mask system of fig. 104;
fig. 114 is a front view of a mouth cushion of the mask system of fig. 104;
fig. 115 is a top view of the mouth cushion of the mask system of fig. 104;
fig. 116 is a bottom view of the mouth cushion of the mask system of fig. 104;
fig. 117 is a right side view of the mouth cushion of the mask system of fig. 104;
fig. 118 is a front view of a mouth cushion of the mask system of fig. 104;
FIG. 119 is a cross-sectional view of the mouth cushion taken along line 119 of FIG. 118;
FIG. 120 is a cross-sectional view of the mouth cushion taken along line 120 and 120 of FIG. 118;
FIG. 121 is a cross-sectional view of the mouth cushion taken along line 121 and 121 of FIG. 118;
FIG. 122 is a cross-sectional view of the mouth cushion taken along line 122-122 in FIG. 118;
FIG. 123 is a cross-sectional view of the mouth cushion taken along line 123 and 123 in FIG. 118;
FIG. 124 is a cross-sectional view of the mouth cushion along line 124 and 124 in FIG. 118;
fig. 125 is a rear isometric view of a cushion clip of the mask system of fig. 104;
fig. 126 is a front isometric view of the cushion clip of fig. 125;
fig. 127 is a top view of the cushion clip of fig. 125;
fig. 128 is a bottom view of the cushion clip of fig. 125;
fig. 129 is a left side view of the cushion clip of fig. 125;
fig. 130 is a rear view of the cushion clip of fig. 125;
FIG. 131 is a cross-sectional view taken along line 131-131 of FIG. 130;
fig. 132 is a front isometric view of a bandage of the mask system of fig. 104;
FIG. 133 is a front view of the bandage of FIG. 132;
FIG. 134 is a rear view of the bandage of FIG. 132;
FIG. 135 is a top view of the bandage of FIG. 132;
FIG. 136 is a bottom view of the bandage of FIG. 132;
FIG. 137 is a right side view of the bandage of FIG. 132;
FIG. 138 is a cross-sectional view taken along line 138 and 138 of FIG. 133;
fig. 139 is a front isometric view of a cushion clip according to an embodiment of the present invention;
fig. 140 is a rear isometric view of the cushion clip of fig. 139;
fig. 141 is a front view of the cushion clip of fig. 139;
fig. 142 is a top view of the cushion clip of fig. 139;
fig. 143 is a bottom view of the cushion clip of fig. 139;
fig. 144 is a left side view of the cushion clip of fig. 139; and
FIG. 145 is a cross-sectional view taken along line 145 of FIG. 141.
Detailed Description
The following description is provided with respect to multiple embodiments that may share common characteristics and features. It is to be understood that one or more features of any one embodiment can be combined with one or more features of other embodiments. In addition, any single feature or combination of features in any embodiment may constitute further embodiments.
In this specification, the term "comprising" should be understood in its "open" sense, that is, in its "closed" sense, that is, in the sense of "consisting only of …". The corresponding terms "comprising", "including" and "comprising", when used in the context of their present, are to be construed to have the corresponding meaning.
The term "air" will be considered to include breathable gases, such as air containing supplemental oxygen. It should be appreciated that the CPAP flow generator systems or blowers described herein may be designed to pump fluids other than air.
1. Mask system
The mask system of the present invention delivers pressurized breathable gas to a patient and includes a nares portion, a mouth portion, a positioning and stabilizing structure, and an air delivery system. The sealing portion may comprise a nares portion and/or a mouth portion to form a seal or substantially seal with the patient's nose and/or mouth. One or more vents may also be included to vent exhaled gases from the patient onto the nares portion and/or the mouth portion. However, the mask may be non-vented and used in hospital/ventilation applications. The mask system may also be provided with an anti-asphyxia valve (AAV).
The sealing portion is arranged to form a seal or substantially seal with the nose and/or mouth of the patient to deliver pressurized gas to the patient. Preferably, the sealing portion has a nares sealing portion and a mouth sealing portion. The nares and mouth sealing portions may be integrally formed, or they may be in the form of separate elements. The nares and mouth seal portions may be connected or otherwise positioned to seal the nose and mouth of the patient, respectively, independently or separately.
A positioning and stabilizing structure may be connected to the sealing portion and adapted to engage the sealing portion with a patient. The positioning and stabilising structure may have upper and lower portions constructed and arranged to avoid the eyes and ears of the patient when in use. The upper and lower portions may be integrally formed with each other, may be separate pieces that are not connected to each other, or may be separate pieces that are coupled to each other. The positioning and stabilising structure may have a rear portion adapted to engage the rear portion of the patient's head in use. The rear portion may interconnect the upper and lower portions.
An air delivery system may connect the sealing portion to the flow generator. The air delivery system may comprise an elbow and/or a tube.
The mask system provides the patient with options for therapy (nasal only, mouth only, or nasal and mouth therapy) without making the system prohibitively expensive and also improving the intuitive use of the mask system. This allows the patient to use the mask system without too much or any indication.
The mask system may be a modular mask system having a nares portion and a mouth portion, wherein the nares portion is adapted to provide respiratory therapy to the nares of the patient without the mouth portion, or the nares portion may be adapted to provide respiratory therapy to the nares and mouth of the patient with the mouth portion, or to provide respiratory therapy to the nares of the patient and to use the mouth portion as a mouth seal.
The mask system may be a modular mask system having a nares portion and a mouth portion, wherein the mouth portion is adapted to provide respiratory therapy to the mouth of the patient without the nares portion, or the mouth portion is adapted to provide respiratory therapy to the nares and the mouth of the patient with the nares portion, or the mouth of the patient with respiratory therapy and using the nares portion as a nares seal.
The mask system may be a unitary mask system having a nares portion and a mouth portion, wherein the nares portion and the mouth portion are unitary and formed as a unitary member. The pressurized gas may be provided to the nares portion and the mouth portion for delivery to the nose and mouth, or the pressurized gas may be delivered only to the nares portion or the mouth portion, with the other portions being blocked from passage of the pressurized gas.
As shown in fig. 1-4, for example, the mask system 1 may include a nares portion 20, a mouth portion 40, and a positioning and stabilizing structure, which may include headgear 60. The air delivery system may deliver air to the mask system 1 through, for example, a flexible tube 5. The mask system of fig. 1-4 is a modular mask system in which the nares portion 20 and the mouth portion 40 are both adapted for use without each other (in a nares only mode or a mouth only mode), or the nares portion 20 and the mouth portion 40 may be used together (in a nares and mouth mode). When used in the nares and mouth mode, one of the nares portion 20 and the mouth portion 40 may be used to deliver pressurized gas, while the other of the nares portion 20 and the mouth portion 40 may be used as a nares seal or a mouth seal. In another form, when used in the nares and mouth modes, both the nares portion 20 and the mouth portion 40 may be used to deliver pressurized gas to the airway of the patient. Alternatively, the mask system 1 may be formed as a unitary mask system in which the nares portion 20 and the mouth portion 40 are formed as a single element.
Fig. 5-1-13 illustrate another mask system 1 that may be in the form of a modular mask in which the nares portion 20 and the mouth portion 40 may be adapted for use without each other, or the nares portion 20 and the mouth portion 40 may be adapted to function together to deliver breathable pressurized gas to the nares and mouth of the patient. In fig. 5-1 and 6-13, the flexible tube 5 is connected to the swivel ring 4 via an elbow 2 to direct pressurized breathable gas to the chamber of the mouth portion 40 and the nares portion 20. Fig. 5-1 and 6-12 show the modular mask system 1 in a nares and mouth mode, in which both the nares portion 20 and the mouth portion 40 are used. Fig. 5-2 show the mask system 1 in the nostril only mode, wherein the nostril portion 20 is used without the mouth portion 40. In the nostril only mode, the elbow 2, flexible tube 5 and swivel ring 4 are connected to an opening in the nostril portion 20.
Fig. 14 and 15 illustrate an integrated mask system 101, the integrated mask system 101 including a nares portion 120, a mouth portion 140, and a positioning and stabilizing structure, which may include headgear 160. In an integrated mask system, the nares portion 120 and the mouth portion 140 are not separable and are typically formed together as a unitary member. The air delivery system may deliver air to the mask system 101 through, for example, a flexible tube 105, the flexible tube 105 being connected to the mouth portion 140 via an elbow 102.
Fig. 16-18 illustrate another mask system 201, which may be a unitary mask system, and which includes a nares portion 220 and a mouth portion 240. The air delivery system may deliver air to the mask system 201.
Fig. 21 and 22 illustrate a modular mask system 301 according to an embodiment of the invention. The mask system 301 includes a nares portion 320, a mouth portion 340, and a headband 360. The air delivery system may deliver air to the mask system 301, such as through a flexible tube 305, the flexible tube 305 being connected to the mouth portion 340 or nares portion 320 via a connector 306 and an optional swivel connector 308. The connector 306 may be in the form of a bent tube or other type of connector. The connector 306 may be a flexible portion capable of absorbing external forces, such as may be caused by tube drag, that may otherwise disrupt the seal of the nares portion 320 and/or mouth portion 340 with the patient. Fig. 21 illustrates the mask system 301 in the nostril only mode, and fig. 22 illustrates the mask system 301 in the nostril and mouth mode.
Fig. 23 illustrates a modular mask system 370 in accordance with an embodiment of the present invention. The mask system 370 includes a nares portion 372, a mouth portion 380, and headgear 360. An air delivery system including an air delivery tube or conduit 379 may deliver air to the mask system 370. Furthermore, tube 379 may be used as a headband in addition to being an air delivery tube or catheter uv.
Fig. 24 illustrates a modular mask system 401 in accordance with an embodiment of the present invention. The mask system 401 includes a nares portion 420, a mouth portion 440, and headgear 460. The air delivery system may deliver air to mask system 401 through, for example, flexible tube 405 being connected to mouth portion 440 via connector 402 and optional swivel connector 444.
Fig. 25 illustrates an integrated mask system 501 in accordance with an embodiment of the present invention. The mask system 501 includes a nares portion 520, a mouth portion 540, and headgear 560. The air delivery system may deliver air to the mask system 501 through, for example, a flexible tube 505, the flexible tube 505 being connected to the mouth portion 540 via a connector 502 and an optional swivel connector 544.
Fig. 34 illustrates a mask system 701 that may be in the form of a modular mask in which the nares portion 720 and the mouth portion 740 may be adapted for use without each other, or the nares portion 720 and the mouth portion 740 function together to deliver breathable pressurized gas to the nares and mouth of a patient. Fig. 34 illustrates mask system 701 used in a nares and mouth mode, with flexible tube 705 connected to swivel rings 710 and 744 via double elbow 712 to direct pressurized breathable gas to chamber and nares portion 720 of mouth portion 740.
In the nostril only mode, only the nostril portion 720 is used, and the mouth portion 740 is not used. In this mode, the double elbow 712 is removed, and the mouth portion 740 is removed. The patient uses only the nares portion 720 and connects the tube 705 with a swivel or other connector 710. An elbow, such as elbow 2, may be used to connect the tube 705 to a swivel or other connector 710.
In the mouth-only mode, only the mouth portion 740 is used and the nares portion 720 is not used. In this mode, the double elbow 712 is removed and the nares portion 720 is removed. The patient uses only the mouth portion 740 and connects the tube 705 to the swivel ring or other connector 744. An elbow, such as elbow 2, may be used to connect tube 705 to swivel ring or other connector 744.
1.1 nostril portion
In use, the nares portions form a seal with the patient's nasal airways. The nares portion may be a seal disposed on the exterior of the patient's nose, such as a cradle mask or a typical nasal mask. Alternatively, the nares portion may surround the nares-type seal similar to a pillow-type mask, or the nares portion may be a nasal-type seal similar to a nasal plug. The nares seal may be an appropriate choice for patients with upper airway obstruction. Breathing through the nose may also have other benefits similar to natural filtration of incoming air.
As shown in fig. 1-4, the modular mask system 1 may include a nares portion 20. The nares portion 20 may include a nares sealing portion 22, a breakaway portion 25, a headgear connector 21, a swivel ring 4, and a plug 3. Headgear connectors 21 may include headgear tabs 31 adapted to connect with headgear.
The separation portion 25 may be used to separate forces applied to the nares portion 20 from the nares sealing portion 22, such as tube drag forces applied to the swivel ring 4 due to movement of the flexible tube 5. The swivel ring 4 fits into an opening in the decoupling portion 25 on the front of the nares portion 20. The separation portion 25 may comprise a thin-walled portion, for example less than 1mm, to give flexibility to the portion.
The plug 3 is adapted to fit into the swivel. The plug 3 may include a plurality of optional vent holes 6 that allow air exhaled by the patient's nose to be expelled from the nares portion 20. Preferably, the vent holes 6 are arranged in a diffusing array to prevent air from being ejected from the vent holes. In some embodiments, the plug 3 may be removed and replaced by a connection to the tube 5.
Figure 1.1 shows the nares portion 20 of the mask system 1 used in the nares only mode. The nares portion 20 is used without the mouth portion 40 and the elbow 2 and flexible tube 5 are connected with the swivel ring 4 on the nares portion 20.
The nares portion 20 shown in figures 1-1 to 4 may be, for example, a Swift commercially available from leismed Ltd (ResMed Ltd)TMModified versions of FX (e.g., as described in WO 2009/052560a1 and WO 2010/139014a1, both incorporated herein by reference in their entirety), but other nares portions may be used. The nares portion 20 may be a Swift commercially available from leismeld limitedTMFX is modified to include a connector 30, as shown in fig. 1-1, 1-5 and 3, the connector 30 adapted to connect with a chamber 49 of the nares portion 20 at an opening 46 of the mouth portion 40 to allow air to flow pneumatically between the nares portion 20 and the mouth portion 40. When used in the nostril only configuration shown in figures 1-1, the connector 30 is removed from the opening 46 as shown in the exploded view of figures 1-5 and the connector 30 is engaged with the plug 35. Plug 35 is shaped to fit into opening 46 or connector 30 as desired. The plug 3 is removed from the nares portion 20 and the elbow 2 and flexible tube 5 may be connected with the nares portion 20 via the swivel ring 4 to deliver pressurized breathable gas to the nares portion 20.
Fig. 5-1 to 13 show a mask system 1 comprising a nares portion 20. The nares portion 20 may include a nares sealing portion 22, a breakaway portion 25, a headgear connector 21, and a swivel ring 4. Headgear connectors 21 may include headgear tabs 31 adapted to connect with headgear 60.
The nares portion 20 shown in figures 5 to 13 may be, for example, a Swift commercially available from leismed limitedTMFX, but other nares portions may be used. Further details of such a nares portion 20 are disclosed in WO 2009/05256A 1, the disclosure of which is totally incorporated herein by referenceThe contents of which are incorporated herein by reference.
Figures 19 and 20 illustrate another nostril portion 220 that may be used with any of the embodiments disclosed herein. The nares portion 220 may include a nares sealing portion 222, a support membrane 252, a support portion 253, and a headgear connector 230, the headgear connector 230 having headgear tabs 231 for connection with a headgear. The support membrane 252 may be adapted to connect with a swivel or other connector for connection with a pressurized supply of breathable gas. Further details of nares portion 220 are disclosed in WO 2010/139014a1, the disclosure of which is incorporated herein by reference in its entirety.
Fig. 14 and 15 show an integrated mask system 1 that includes a nares portion 120. The nares portion 120 may include a nares sealing portion 122, a breakaway portion 125, and a headgear connector 121 adapted to connect with a headgear 160. Nostril portion (such as the commercially available SwiftTMFX nostril part, commercially available SwiftTMA modified version of the FX nostril portion or nostril portion in fig. 19 and 20) may be used and may be integrated with the embodiment of fig. 14 and 15.
Fig. 16-18 illustrate a mask system 201 that may include a nares portion 220. The nares portion 220 may include a nares sealing portion 222 and an orifice 226 for receiving pressurized breathable gas. The mask system 201 is shown with a nares portion 220 such as that shown in fig. 19 and 20, but other nares portions may be used, such as the commercially available SwiftTMFX nostril part or commercially available SwiftTMModified version of the nostril portion FX.
Fig. 21 and 22 show a modular mask system 301 that includes a nares portion 320. The nares portion 320 may include a nares sealing portion 322, a breakaway portion 325, and a headgear connector 321 for connecting with a headgear 360. The nares portion 320 may be adapted to connect with the connector 306 by including an opening 326 adapted to receive the connector 306.
Fig. 23 shows an integrated mask system that includes a nares portion 372 and a headgear 360 connected to a mouth portion 380. Nares portion 372 includes a nares sealing portion 374 adapted to form a seal with the patient's nares.
Fig. 24 shows an integrated mask system 401 that includes a nares portion 420 and a headband 460 connected to a mouth portion 440. The nares portion 420 includes a nares sealing portion 422 adapted to form a seal with the nares of the patient, a breakaway portion 425, and a headgear connector 421 adapted to connect with a headgear 460. The nares portion 420 is illustrated as a type of membrane shown in figures 19 and 20, but other nares portions may be used, such as the commercially available SwiftTMFX nostril part or commercially available SwiftTMModified version of the nostril portion FX.
Fig. 25 shows an integrated mask system 501 that includes a nares portion 520 and a headband 560 connected to a mouth portion 540. The nares portion 520 includes a nares sealing portion 522 adapted to form a seal with the nares of the patient, a decoupling portion 525, and a headgear connector 521 adapted to connect with a headgear 560. The nares portion 520 is illustrated as a type of membrane shown in figures 19 and 20, but other nares portions may be used, such as the commercially available SwiftTMFX nostril part or commercially available SwiftTMModified version of the nostril portion FX.
Fig. 34 shows a modular mask system 701 that includes a nares portion 720 connected to a mouth portion 740, and headgear 760. The nares portion 720 includes a nares sealing portion 722 adapted to form a seal with the nares of the patient, a breakaway portion 725, and a headgear connector 721 adapted to connect with a headgear 760. The nares portion 720 may be a commercially available SwiftTMFX nostril portion, however, other nostril portions may be used, such as the commercially available SwiftTMThe nostril portion FX or nostril portion shown in fig. 19 and 20.
Figures 55, 55A, 56, and 56A illustrate nostril portions 1380, 1390 including foam portions 1382, 1392, respectively. The foam portions 1382, 1392 have holes 1384, 1394 that allow air to pass through to the patient's nares. As shown in fig. 55A, the foam portion 1382 is compliant and will appear as a nasal prong once compressed. As shown in fig. 56A, the nose prongs curl back to hold the foam portion 1392 in place and provide a relatively flat surface for contact with the nose.
1.2 mouth part
The mouth portion may be adapted to surround the mouth of the patient and form a seal with the airway at the mouth of the patient. The seal of the mouth portion may be a sheet type seal similar to a film type seal, or may be a compression seal using materials such as foam, gel, fabric, etc.
The mouth portion 40 as shown in fig. 1-2-4 may include a mouth seal portion 42, a separating portion 45 that separates a force applied to the mouth portion 40 from the mouth seal portion 42, a lower headgear connector 41, and a swivel connector 44. The mouth portion 42 forms a chamber 49 into which air can be delivered and directed to the patient's mouth.
The swivel connector 44 may be disposed in the front aperture 52 of the mouth portion 40. Swivel connector 44 may be a swivel ring adapted to connect with a tube connector, such as elbow 2, for connection with flexible tube 5, which flexible tube 5 may deliver breathable gas to mouth portion 40. The rotating connector 44 may be removed from the front aperture of the mouth portion 40. Alternatively, the tube 5 may be directly connected to the mouth portion 40.
The mouth portion 40 shown in figures 1-4 is also adapted to be connected to the nares portion 20. Specifically, as shown in fig. 1-4 and 1-5, the mouth portion 40 may include a hole or opening 46, the hole or opening 46 adapted to receive the connector 30 of the nares portion 20 and seal with the connector 30 of the nares portion 20 to pneumatically connect the nares portion 20 with a chamber 49 of the mouth portion 40. A plug 35 may be included in the mask system 1, the plug 35 being adapted to fit into the connector 30 or the aperture 46 and plug the connector 30 or the aperture 46. Also, the nares portion 20 may function in the nares-only mode without the mouth portion 40.
The mouth portion 40 may serve as a docking interface, wherein the mouth portion 40 is adapted to provide docking with respect to the nares portion 20 (the mouth portion is adapted to removably receive the nares portion). As shown in fig. 1-5, the mouth portion may include a nares portion interface 56 formed on the mouth portion 40, wherein the nares portion interface 56 is adapted to receive the nares portion 20. The received nares portion 20 can serve as a nares-only device for delivering pressurized breathable gas to the nares of the patient.
The nares portion interface 56 may be adapted to receive the nares portion 20 by having a selected shape that matches the shape of the nares portion. For example, as shown in figures 1-5, the nares portion interface may have a curved upper surface to match the curved lower portion of the mouth portion 40. The nares portion interface 56 may be adapted to receive the nares portion 20 by having an opening or hole, such as hole 46, adapted to receive a protrusion, such as connector 30, or a connector in the nares portion 20. Alternative connections to the interface 56 and the nares portion 20 are possible, such as using undercuts or grooves to hold the nares portion 20 in place. A plug 35 may be provided, the plug 35 being adapted to plug the connector 30 or the opening 46.
When the connector 30 of the nares portion 20 is connected with the mouth portion aperture 46, a plug 35 may be placed in the connector 30 to prevent air from pneumatically flowing between the nares portion 20 and the mouth portion 40. Optionally, the mouth portion 20 may be adapted to prevent air from pneumatically flowing between the nares portion 20 and the mouth portion 40 by including a valve 55 as shown in fig. 3, the valve 55 selectively opening and closing the opening 46. The patient can selectively operate the valve 55, such as by turning the knob 54 shown in fig. 2 and 3.
In some embodiments, such as shown in fig. 1-3, elbow 2 and flexible tube 5 may not be connected to swivel connector 44, but instead are replaced by plug 3, which plug 3 may or may not include optional vent 6.
Fig. 5-1-13 show a modular mask system 1 that includes a mouth portion 40, the mouth portion 40 including an alternative connector to connect to the nares portion 20. In particular, in the embodiment of figures 5-1 to 13, the nares portion connector 43 is used to connect the mouth portion 40 with the nares portion 20. The nares portion connector 43 is adapted to fit over the nares portion 20 and seal with the nares portion 20 so that air from the flexible tube 5 may be delivered to the mouth portion 40 and through the nares portion connector 43 to the nares portion. The decoupling portion 45 may decouple forces at the swivel 4 (such as tube drag) from the sealing portion 22 of the nares portion 20 and from the sealing portion 42 of the mouth portion 40.
The sealing portion 42 of the mouth portion 40 may include a bottom 79, sides 81, a top 85, and a neck 87. The bottom portion 79 may be adapted to form a seal with the patient's lower lip region or chin region. The top portion 85 may be adapted to form a seal with the upper lip area of the patient. The side portion may be adapted to form a seal with the patient's face over a side region of the patient's mouth. Side 81 extends between bottom 79 and top 85. A neck 87 connects the top 85 with the nares portion connector 43. The sealing portion 42 transitions entirely from the top 85 into a neck 87, the neck 42 being narrower than the top 85 to conform to the size and shape of the nares portion connector 43. By making the neck portion 42 narrower, the pressure and the air flow into the seal portion 42 can be improved.
Fig. 14 and 15 show a mask system 101 including a mouth portion 140. The mouth portion 140 may include a structural portion 147, a mouth seal portion 142, a breakaway portion 145, a headgear connector 141 for connection to headgear, and a vent 103, which vent 103 may include one or more vent holes or slots for venting gases exhaled by the patient. When the nares portion 120 and the mouth portion 140 are not formed as a unitary member, a nares portion connector 143 for connecting with the nares portion 120 may be used. The flexible tube 105 may be connected with the mouth portion 140 via the elbow 102. The structural portion 147 can be constructed and arranged to harden the outer perimeter of the sealing portion to maintain the shape of the sealing portion and apply sufficient sealing force to the patient's face.
Fig. 16-18 show a mask system 201 that includes a mouth portion 240. The mouth portion 240 includes a mouth sealing portion 242, which may be in the form of a cushion for sealing with the patient's mouth, a frame 247, a mouth orifice 246 for receiving pressurized breathable air, a separating portion 245, and a nares connecting portion 243 for connecting with the nares portion. Illustrated in fig. 16 is the frame 247, the separating portion 245 and the connecting portion 243 removed. Although not shown, the mouth portion may include connections to flexible tubing to deliver pressurized breathable gas, such as the swivel connectors, elbows, and flexible tubing shown in other embodiments.
Fig. 21 and 22 show a modular mask system 301 that includes a mouth portion 340. The mouth portion 340 includes a breakaway portion 345, an opening 348, and a connector 349. The connector 306 is adapted to connect with the opening 326 in the nares portion 320 as shown in figure 21 or with the opening 348 in the mouth portion 340 as shown in figure 22. The connector 349 of the mouth portion is adapted to connect with the opening 326 in the nares portion 320 when the mask 301 is used in a nares and mouth mode. The plug may be provided to plug the connector 349 when the mask 301 is used in the mouth-only mode.
The mask system 375 shown in fig. 23 may include a mouth portion 380. The mouth portion 380 may include a mouth sealing portion 375 and may be adapted to connect with the headband 360 and with the nares portion 372. The mask system may include an air delivery conduit or tube 379 that may be integrated into the headgear. Thus, the air delivery tube 379 eliminates the need for an elbow connected to the mouth portion 380, provides "ducted" air delivery and gives the mask system 375 a more streamlined appearance.
The mask system 401 shown in fig. 24 includes a mouth portion 440. The mouth portion 440 includes a mouth sealing portion 442, a headband connector 441 for connection with a headband 460, and a separating portion 445. Swivel connector 444 may connect the mouth portion 440 with the elbow 402 and flexible hose 405, with the elbow 402 and flexible hose 405 delivering pressurized breathable gas to the mask system 401.
The mask system 501 shown in fig. 25 includes a mouth portion 540. The mouth portion 540 includes a mouth seal portion 542, a headgear connector 541 for connecting with headgear 560, a swivel connector 544, and a foam patient contact portion 569. The foam may be placed around the perimeter of the mouth sealing portion 542, but may alternatively be placed only at selected portions, for example, only at the upper lip for comfort. Silicone or another sealing means may be placed in the area around the perimeter of the mouth sealing portion 542 that does not contain foam. The mouth portion 540 may also include an optional breakaway portion 545. Swivel connector 544 may be connected to elbow 502 and flexible hose 505, elbow 502 and flexible hose 505 delivering pressurized breathable gas to mask system 501. The foam patient contact portion 569 may contact and form a seal with the patient's upper lip area, and thus form part of the mouth seal.
The mask system 701 shown in fig. 34 includes a mouth portion 740. The mouth portion 740 may include a mouth sealing portion 742, a separating portion 745, and a headgear connector 741 for connecting with the headgear 760. A swivel ring or other connector 744 may also be used to connect with the flexible hose 705 via the double elbow 712.
1.3 sealing part
The sealing portion may be composed of at least two portions: a nares sealing portion and a mouth sealing portion. By providing at least a nares sealing portion and a mouth sealing portion, the patient may selectively receive pressurized breathable gas through their nose and/or mouth.
The nares sealing portion may function independently of the mouth sealing portion. Thus, in some embodiments, the patient may remove the mouth seal portion by removing the mouth portion and only use the nares portion with the nares seal portion as desired. The mouth seal portion may function independently of the nares seal portion. Thus, in some embodiments, the patient may remove the nares portion and the nares sealing portion and use only the mouth portion and the mouth sealing portion.
Both the nares and mouth sealing portions need to form a seal with the upper lip of the patient. However, because of the limited amount of surface area in which the nares and mouth seal portions are positioned in the upper lip region, various embodiments use structural components to achieve sealing of both the nares and mouth seal portions in the patient's labial region.
The mouth seal portion may be adapted to fit a wide range of people. The mouth seal portion may have a single size that fits most people. However, the mouth seal portion may be provided in a variety of sizes to accommodate a wide range of people. The mouth seal is longitudinally adjustable to accommodate people of different anthropometric ranges.
The nares sealing portion may be adapted to a wide range of people. Preferably, the nares sealing portions may be provided in one or two sizes to accommodate a wide range of people.
1.3.1 nostril sealing part
The nares sealing portion is adapted to provide a comfortable and effective seal with the nares of the patient.
The nares sealing portion may be in the form of a pillow, a prong, a membrane seal such as a nasal cradle, and/or a nasal chamber.
The nares sealing portion may be a pillow seal such as disclosed in PCT application No. WO 2009/052560a1, the entire contents of which are incorporated herein by reference.
Preferably, the nares sealing portion may be flexible and conformable to conform to the shape of the patient's nose and/or nares in use.
Preferably, the nares sealing portion may be constructed from a polymer such as silicone, thermoplastic elastomer, thermoplastic urethane. Alternatively, the nares sealing portion may be constructed of foam, gel, fabric, or other compliant material. Alternatively, the nares sealing portion may be constructed from a combination of materials such as a foam and fabric laminate, a fabric and polymer combination, or any other combination of the above.
As shown in fig. 1-4, embodiments of the present invention may include a nares sealing portion 22 in the form of a pillow-type or prong-type nares seal. The nares sealing portion 22 may alternatively be a membrane-type nares seal or a nasal chamber. The nares sealing portion 22 is adapted to form a seal with the nares of the patient in use. The nares sealing portion 22 may be positioned to lie under the nose of the patient and shaped to form an effective seal.
As shown in fig. 19 and 20, the nares portion 220 may include a nares sealing portion 222, a support membrane 252, a support portion 253, and a headgear connector 230, the headgear connector 230 having headgear tabs 231 for connection with a headgear. When using a thin film style nares portion, all embodiments disclosed herein may use a nares sealing portion in the form of a nares sealing portion 222.
The nares sealing portion 222 may include a nose tip engagement portion 254, an upper lip engagement portion 256, and a thickened corner region 258. Support portion 253 may include a rear thickened portion 262 and a front thickened portion 260. A higher durometer material in portions of support portion 253 may be used in place of thickened portions 260 and 262 or in conjunction with thickened portions 260 and 262 to provide additional support in these areas. Front thickened portion 260 is positioned adjacent to the region of the sealing portion that contacts the sides of the patient's nose in use and converts headgear loads into clamping forces on the sides of the patient's nose to provide an effective seal. Front thickened portion 260 may have a thickness that increases from top to bottom. Rear thickened portion 262 may include a lower portion 266 having a first thickness and an upper portion 264 having a second thickness that is thicker than the first thickness.
The nose tip engaging portion 254 is formed as a suspended flexible membrane. The sides of the sealing portion 222 are connected or joined with the support portion 253, while an anterior gap exists between the support portion 253 between the central portion of the sealing portion 222 and the anterior anchor point 257. By using this suspended flexible membrane, the nose tip engagement portion 254 provides a flexible surface that maintains tensile contact with the nose during movement of the patient interface and better accommodates different nose geometries. The nose tip engagement portion 254 engages and seals with the patient's nose and extends toward the support portion 253. The sides of the sealing portion 222 engage and seal with the sides of the patient's nose.
The sealing portion 222 includes an upper lip engaging portion 256 that engages the upper lip of the patient in use. The upper lip engaging portion 256 is formed as a suspended flexible film with a back gap between the upper lip engaging portion 256 of the sealing portion 222 and the supporting portion 253. The rear gap is positioned between rear anchor points 259 that anchor seal portion 222 to support portion 253. The flexible suspended membrane provides a flexible surface that remains in tensile contact with the patient's upper lip during movement of the patient interface and can stretch to accommodate different facial geometries by allowing the upper lip engaging portion 256 to move.
Rear thickened portion 262 may have a curved portion 268. The rear thickened portion 262 may include a cored-out portion 270 to reduce the volume of silicone and reduce healing time. The rear thickened portion 262 is positioned directly below the thickened corner region 258 of the seal portion 222, as can be seen in fig. 20. When used with headgear connectors as shown in fig. 24 and 25, the rear thickened portion 262 transfers load from the headgear connector to the thickened corner region 258 and to the lower corner of the patient's nose, thereby helping to provide an effective seal and increasing the load transferred to the lower corner of the patient's nose when the headgear is tensioned. In use, bending forces from the headgear connectors are transferred by the rear thickened portion 262 to the thickened corner region 258 of the sealing portion 222, thereby applying the sealing force as an anchoring force to the region of the patient's nose adjacent the nasolabial folds.
The nares sealing portion 222 is configured to extend or curve outwardly from the support wall 221 formed in a bore 226 defining an air path through the nares portion 220.
Further details of the nares sealing portion 222 are disclosed in WO 2010/139014a1, the disclosure of which is incorporated herein by reference in its entirety.
All of the embodiments disclosed herein may use a nasal chamber or nares sealing portion in the form of a pillow or prong-type nares seal, a membrane-type nares seal, such as shown in figures 19 and 20.
Figures 35 and 36 illustrate a nares sealing portion 820 that may be used to form a seal with a patient's nares to deliver pressurized breathable gas to the patient's nares via an opening 826 and an inlet tube 830 in the mask system. The nares sealing portion 820 may be a thin film type nares seal, such as the sealing portion 222 shown in figures 19 and 20.
A dial 822 or rigid element 823 is disposed on the bottom surface of the nares sealing portion 820. There may be four such rigid elements 823, but any number of rigid elements may be used. Rigid element 823 may be disposed to extend radially from dial 822, and dial 822 may be disposed about opening 826. Turning the dial 822 will rotate the bevel gear causing the rigid element 823 to move up or down, which in turn causes the sides of the nares sealing portion 820 to move up or down, increasing or decreasing the clamping force on the sides of the patient's nares in use.
1.3.2 mouth seal portion
The mouth seal portion may be adapted to seal with the mouth of the patient. Preferably, the mouth seal portion may be flexible and conformable so as to conform to the shape of the patient's nose and/or nares in use. The mouth seal portion may comprise a membrane that is capable of stretching over the patient's upper lip and chin region, i.e., is more flexible than the side regions of the membrane that interface with the patient's cheeks. The cheek or mouth side regions are less sensitive to pressure due to mask forces and therefore more force may be applied to the cheek or side regions, anchoring the mouth portion to the patient's mouth. Furthermore, the flexibility of the upper lip region and chin region means that the mouth seal portion is able to flex from a substantially planar position to fit a flat/flat face, and is also able to fit a pointed/angular face by flexing to a recessed position.
Preferably, the mouth seal portion may be constructed from a polymer such as silicone, a thermoplastic elastomer, or a thermoplastic urethane. Alternatively, the mouth sealing portion may be constructed from foam, gel, fabric, or other compliant material. Alternatively, the mouth sealing portion may be constructed from a combination of materials such as a foam and fabric laminate, a fabric and polymer combination, or any other combination of the above.
As shown in fig. 1-1 through 4, embodiments of the present invention may include a mouth seal portion 42. The mouth sealing portion 42 is adapted to form a seal with the mouth of the patient in use. The mouth seal portion 42 may be positioned to lie around the mouth of the patient and shaped to form an effective seal. The mouth sealing portion 42 may be in the form of a cushion that forms a rear opening 50 for insertion of the patient's mouth. The cushion may be a soft silicone cushion that contacts and forms a seal with the patient's mouth region. All embodiments disclosed herein may include a mouth seal portion as described above.
As shown in the schematic cross-sectional view of fig. 26, the mouth seal portion 42 may seal with the patient around the patient's mouth in the region of the patient's upper lip and in the region between the patient's lower lip and the patient's chin. As further illustrated in fig. 26, the mouth seal portion 42 may be disposed between the separating portion 25 and the patient's upper lip.
Most preferably, the mouth seal portion may be formed of a leaf seal, such as the one disclosed in U.S. patent 7,658,189, which is incorporated herein by reference in its entirety. The mouth seal portion may be formed of a double-walled seal or a single-walled seal.
1.3.3 isolation
There may be a separate element or a force absorbing element arranged as part of the nares portion or the mouth portion. The separation element may be positioned between the first portion of the nares portion and the second portion of the nares portion, and/or between the first portion of the mouth portion and the second portion of the mouth portion, to prevent movement or forces acting on the nares portion or the mouth portion from breaking the seal of the respective sealing portion.
In an embodiment, the separating element may be a spring. In another embodiment, the separation element may be a gusset or a flexible chamber.
As shown in fig. 1-4, the separation portion 25 may be disposed between the nares sealing portion 22 and the swivel ring 4. The separating portion 25 may be a thin, flexible region of resilient material adapted to absorb forces and/or movements by flexing and/or changing its shape. For example, the separation portion 25 separates forces or motions acting on the swivel ring 4 to prevent their transfer to the nares sealing portion 22.
The mouth seal portion 40 may also include a breakaway portion 45, and the breakaway portion 45 may be disposed between the frame 47 and the swivel connector 44. The separation portion 45 may be a thin, flexible region adapted to absorb forces and/or movements by flexing and/or changing its shape. For example, the breakaway portion 45 breaks away forces or motions (such as tube drag forces) acting on the flexible tube 5, swivel connector 44, and/or elbow 2 to prevent them from being transferred to the mouth seal portion 42, providing a more effective seal with the patient. All embodiments disclosed herein may include one or more separate portions of the component that may be a nares portion and/or a mouth portion as described.
In the mask system 1180 of fig. 46, the nares portion 1190 is separated from the motion in the mouth portion 1182 by a separation portion 1181. The separating portion 1181 allows the nares portion 1190 to remain in sealing engagement with the patient's nares if the air hose 1185 and/or the mouth portion 1182 moves. The nares portion 1190 may rotate relative to the mouth portion 1182. Cover piece 1183 will move with air hose 1185 and/or mouth portion 1182.
1.3.4 relationship between nares sealing portion and mouth sealing portion
The sealing portion may be constructed as a unitary member that includes a nares sealing portion and a mouth sealing portion.
The sealing portion may be constructed as more than one member, which may then be joined together to work as a nares and mouth mask. For example, the nares sealing portion may be comprised of a first member and the mouth sealing portion may be comprised of a second member, and the first and second members may then be joined together.
In another preferred embodiment, the sealing portion may be constructed of more than one component, wherein each component may be used independently of or joined with the other components, each arrangement still providing treatment to the patient. For example, the nares portion including the nares sealing portion may be separate from the mouth portion including the mouth sealing portion, and the nares portion including the nares sealing portion may be used without the mouth portion including the mouth sealing portion attached, while still being able to deliver therapy to the patient's nares.
1.3.5 connection of nares and mouth parts to headgear
A headband 60 can be connected with each of the nares portion 20 and the mouth portion 40. This is different from many prior art arrangements in which the headband is connected only to the mouth portion, and the mouth portion is constructed and arranged such that the nares portion is adapted for sealing engagement with the nose of the patient.
As shown in fig. 1-13, the nares portion 20 may include a headgear connector 21. The headgear connectors 21 may include headgear tabs 31, and the headgear tabs 31 may interface or connect with apertures 62, which may be in the form of slots or loops, on the headgear straps 61.
The mouth portion 40 may include a lower headgear connector 41 for receiving a locking arrangement 64 from a lower headgear strap 63.
Alternative attachment means may be used for the nares portion 20 and the mouth portion 40. For example, hook and loop type connections, press fit connections, interference fits, ball and socket joints, etc. may be used.
1.4 positioning and stabilizing Structure
The positioning and stabilizing structure in the form of headgear 60 may be adapted to maintain the mask system in sealing engagement with the nares and mouth of the patient. The headgear 60 may include straps adapted to secure the position of the headgear 60 on the patient's head. The straps may include side strap headgear straps 61, a lower headgear strap 63, a rear headgear portion 65, and a crown headgear portion 66. The strap may also direct tension on the mask suitable for sealing the mask to the patient's face.
1.4.1 headband sides
Figures 1-3 and 5-1-7 show the headband 60 in use. Side headgear straps 61 may be adapted to be positioned over the cheeks, under the eyes, and over the ears of the patient. The side headgear straps 61 may be connected with the headgear connectors 21 of the nares portion 20.
The side headgear straps 61 may include side headgear connectors 62 for connection with the headgear connectors 21 of the nares portion 20. The side headgear connectors 62 may be in the form of loops for capturing the headgear tabs 31 on the nares portion 20. Any attachment method may be used, such as hook and loop attachment, clips, press fit bumps. Alternatively, the side headgear straps 61 may be integrally formed with the nares portion 20.
The side headgear straps 61 may preferably be constructed of a flexible material that is capable of longitudinal expansion. Side straps 61 may be constructed of fabric, foam, a combination of foam and fabric, silicone, nylon, elastomer, or any other flexible material.
The side headgear straps 61 may provide an upward vector to the mask system 1 to help maintain the mask system 1 in a desired position. The upward vector may be angled upward relative to the vector applied by the lower headgear strap 63.
1.4.2 headband crown part
The headgear 60 may further include a crown strap portion or top strap 66, which may be adapted to be positioned on top of or over the crown of the patient's head in use. The overhead strap portion 66 may provide an upward vector to the mask system to help maintain the mask system in a desired position.
The crown strap portion 66 may be spliced or otherwise connected to the side headgear straps 61. The crown strap portion 66 and/or the side headgear straps 61 may further include a strap loop 68. The strap ring 68 may be configured to receive the rear portion 65.
The overhead strap portion 66 may further include an adjustment mechanism 69. The adjustment mechanism 69 may be the adjustment mechanism described in WO 2009/052560a1, the entire content of which is incorporated herein by reference.
The crown strap portion 66 may preferably be constructed of a flexible material capable of longitudinal expansion. The overhead strap portion 66 may be constructed from fabric, foam, a combination of foam and fabric, silicone, nylon, elastomer, or any other flexible material.
1.4.3 lower part of headband
The headgear 60 may further include a lower headgear strap 63, and the lower headgear strap 63 may be connected to the mouth portion 40 of the mask system 1. The lower headgear straps 63 may direct the tensioning force on the mouth portion 40 to provide a vector force perpendicular to the patient's face and thus provide a seal of the mouth portion 40 on the patient's face.
The lower headgear strap 63 may be a strap oriented generally below the patient's ear.
The lower headgear straps 63 may be connected to or otherwise formed with the rear headgear portion 65.
1.4.4 rear of headband
The headgear 60 may further include a rear portion or strap 65. The back portion 65 may be continuous with or otherwise attached to the side headgear straps 61 or the crown strap portion 66, or the side headgear straps 61 or the crown strap portion 66. The rear portion 65 may pass through the strap ring 68 and be positioned over the ear of the patient. The rear portion 65 may travel down the side of the patient's head and capture the occiput to anchor the headgear 60 in place when in use. Rear portion 65 may further attach to lower headgear strap 63 in connection region 67.
The rear portion 65 may provide a downward and rearward (i.e., away from the patient's face) vector to balance the upward vector of the overhead strap portion 66 and to help pull the mask system 1 into sealing engagement with the patient's face.
The posterior portion 65 may be secured in place under the patient's occiput by attachment to the lower strap 63 (see fig. 7). The attachment may be made in the connection region 67. The connection region 67 may comprise a sewn bond, a hook and loop bond, or any other bond. The attachment region 67 may also be a permanent bond such that the rear portion 65 and the lower strap 63 are formed as a unitary member.
The rear portion 65 may preferably be constructed of a flexible material capable of longitudinal expansion. The back portion 65 may be constructed from fabric, foam, a combination of foam and fabric, silicone, nylon, elastomer, or any other flexible material.
1.4.5 headband selection
Various mask system and kit embodiments may include various headgear options such as that shown in fig. 33. For example, when used in the nostril only mode, a nostril portion headgear 812 adapted to secure the nostril portion to the patient's head may be used. When used in the mouth-only mode, a mouth portion headband 850 adapted to secure the mouth portion to the patient's head may be used.
Nares portion headgear 812 uses headgear vectors that are angled upward to align nares sealing forces with the patient's nares. The mouth portion headgear 850 uses headgear vectors that are oriented generally in a horizontal plane to align the mouth seal force with the patient's mouth. In the example shown in fig. 33 and 37-38, the headband vectors are angled with respect to each other. However, in the example of fig. 40-41, the headband vectors are substantially parallel to each other due to the nature of the cushion and the sealing forces involved.
When used in the nares and mouth mode, the nares portion headgear 812 and the mouth portion headgear 850 may be used together to secure the nares portion and the mouth portion to the patient's head. Alternatively, a nares and mouth portion headband 860 may be used that includes an attachment region in the posterior portion, such as the attachment region 67 shown in fig. 7. The nares and mouth portion headgear 860 generates headgear vectors that run back up the patient's head to secure the nares portion 820 to the patient's nares, and headgear vectors that run back up the patient's head to secure the mouth portion 840 to the patient's head.
Also, a connected nares and mouth portion headband 870 may be used that includes connectors 856 for connecting a nares-only headband and a mouth-only headband in the posterior portion. The connector 856 may be a hook and loop (Velcro) connector, a hook and loop material connector, or the like. Any of the headband options described above may be used with the various embodiments.
Other alternatives for allowing selective attachment and detachment are possible, such as seen in fig. 66 described below, which includes a rear ring member 1622 through which a rear strap 1699 extends.
Another variation is shown in fig. 90 and 91, which illustrate another option for converting from a two-point headband to a four-point headband. The headgear 2000 includes two-point headgear 2001, as shown in fig. 33 and 66, the two-point headgear 2001 includes a pair of front straps that support the mask. In addition, the rear portion of the headgear 2000 includes a first rear strap 2002 connected to a pair of front straps and a second rear strap 2006 connectable to the first rear strap by, for example, a press stud or a snap. In particular, first rear strap 2002 may have a recess 2002.1, and second rear strap 2006 may have a complementary portion/recess 2006.2 to allow for selective attachment and detachment.
1.5 Vent
Embodiments of the present invention may use one or more vents in the mask system to vent gases exhaled by the patient. One or more vents may be arranged to vent exhaled gases from the nares portion 20, from the mouth portion 40, or from both the nares portion 20 and the mouth portion 40.
For example, the plug 3 is included on the nares portion 20 and may include a vent 6, the vent 6 venting gases exhaled from the patient's nares. A further vent 6 is optionally included on the elbow 2 connected to the mouth portion 40 to vent exhaled gas from the patient's mouth. If one of the nares portion 20 or the mouth portion 40 is to be used as a sealing portion (e.g., a portion that does not deliver breathable gas to the patient), either of the vents 6 may be eliminated.
The vent 6 may be in the form of a series of individual vent holes or an array of individual vent holes. Alternatively, the vent 6 may be in the form of a slot or series of slots, such as shown in fig. 5 and 6, or another hole or holes.
1.6 air delivery System
Air in the form of pressurized breathable gas is delivered to the mask system 1 through the flexible tube 5. The flexible tube 5 is coupled to a blower/humidifier or other air delivery device adapted to deliver pressurized breathable gas to a patient to provide therapy.
1.7 Modular mask System
Embodiments of the mask system disclosed herein may be a modular mask system that includes a nares portion, a mouth portion, and a headband. The modular mask system may be adapted to allow a patient to selectively use the nares portion and/or the mouth portion in the first mode and the second mode. In the first mode, the patient may use both the nares portion and the mouth portion. In the second mode, the patient may use only the nares portion and not the mouth portion.
Some embodiments may also allow the modular mask system to be used in a third mode in which the mouth portion is used and the nares portion is not used. In embodiments providing the third mode, the mouth portion is used to provide air to the patient's mouth without the user using and wearing the nares portion. Additionally, in some embodiments, the nares portion and the mouth portion may be adapted to allow air to flow freely between the chambers of the nares portion and the mouth portion, such as openings and/or connectors between the chambers. Some embodiments may include a plug or selectively operated valve that may be used to plug the opening or connector to prevent air from flowing between the nares portion and the mouth portion. The plug may also be used to plug the opening or connector when only the nares portion or mouth portion is used. All of the modular mask systems may optionally be formed as a unitary mask system, i.e., the nares portion is not separately usable and it is not separable from the mouth portion.
Figures 32(a) to 32(k) are schematic illustrations of the nares portion 20 and mouth portion 40 used in various modes. In the first mode, the patient may use both the nares portion and the mouth portion by using the nares portion 20 to deliver air to the patient's nares while using the mouth portion 40 to deliver air to the patient's mouth, as shown in fig. 32(e), 32(f), 32(g), 32(h), and 32 (k). In figure 32(e), the nares portion 20 and the mouth portion 40 do not include a connection between the chambers of the nares portion and the mouth portion, and pressurized air is applied separately to both the nares portion 20, which delivers air to the patient's nares, and the mouth portion 40, which delivers air to the patient's mouth. In fig. 32(f), there is a connection between the chamber of the nares portion 20 and the chamber of the mouth portion 40. Pressurized air is applied to the chamber of the mouth portion 40 and flows through the mouth portion 40 to the patient's mouth and from the mouth portion 40 through the connection to the nares portion 20 and to the patient's nares.
In fig. 32(g), there is a connection between the chamber of the nares portion 20 and the chamber of the mouth portion 40. Pressurized air is applied to the chamber of the nares portion 20 and flows through the nares portion 20 to the patient's nares and from the nares portion 20 through the connection to the mouth portion 40 and to the patient's mouth. In fig. 32(h), there is a connection between the chamber of the nares portion 20 and the chamber of the mouth portion 40. Pressurized air is applied to the chamber of the nares portion 20 and the chamber of the mouth portion 40 and may flow through the connection between the nares portion 20 and the mouth portion 40. In figure 32(k), there is a connection between the chamber of the nares portion 20 and the chamber of the mouth portion 40, but the connection is blocked by a plug, valve or the like. The pressurized air is applied to the chamber of the nares portion 20 and the chamber of the mouth portion 40 and flows through the nares portion 20 to the patient's nares and through the mouth portion 40 to the patient's mouth.
In the first mode, the patient may also use both the nares portion 20 and the mouth portion 40 by using the nares portion 20 as a nares seal while using the mouth portion 30 to deliver air to the patient's mouth, as shown in fig. 32(c) and 32 (i). In figure 32(c), there is no connection between the nares portion 20 and the mouth portion 40, and pressurized air is delivered to the patient's mouth through the mouth portion 40, while the nares portion acts as a nares seal. In figure 32(i), there is a connection between the nares portion 20 and the mouth portion 40, but the connection is blocked by a plug, valve or the like. The pressurized air is delivered to the patient's mouth through the mouth portion 40, and the nares portion 20 acts as a nares seal.
In the first mode, the patient may use both the nares portion 20 and the mouth portion 40 by using the nares portion 20 to deliver air to the patient's nares while using the mouth portion 40 as a mouth seal, as shown in figures 32(d) and 32 (j). In figure 32(d), there is no connection between the nares portion 20 and the mouth portion 40, and pressurized air is delivered to the patient's mouth through the nares portion 20, while the mouth portion 40 acts as a mouth seal.
In the second mode. As shown in fig. 32(a), the nares portion 20 is used by the patient alone to deliver air to the patient's nares without the patient using and wearing the mouth portion. In embodiments using a connection that allows air to flow between the nares portion and the mouth portion, a plug, valve, or the like may be used to plug the opening when the nares portion 20 is used alone.
In the third mode, as shown in fig. 32(b), the patient uses the mouth portion 40 alone to deliver air to the patient's mouth without the patient using and wearing the nares portion 20. In embodiments using a connection that allows air to flow between the nares portion 20 and the mouth portion 40, a plug, valve, or the like may be used to plug the opening when the mouth portion 40 is used alone.
The embodiment of fig. 1-4 is a modular mask system 1 in which a patient may use the nares portion 20 in a nares only mode without the mouth portion 40, the patient may use the mouth portion 40 in a nares only mode without the nares portion 20, and the nares portion 20 and the mouth portion 40 may be used together in a nares and mouth mode. Fig. 1-2 and 2-4 illustrate the mask system 1 in a nares and mouth mode in which the nares portion 20 is used with the mouth portion 40. When the mask system 1 is used in the nares and mouth mode, the mask system 1 may deliver air to the patient's nares using the nares portion 20 and deliver air to the patient's mouth using the mouth portion 40, the mask system 1 may deliver air to the patient's nares using the nares portion 20 and the mouth portion 40 may function as a mouth seal that does not deliver air to the patient's mouth, or the mask system 1 may deliver air to the patient's mouth using the mouth portion 40 and the nares portion 20 may function as a nares seal that does not deliver air to the patient's nares.
Both the nares portion 20 and the mouth portion 40 are adapted to be connected to a source of pressurized breathable gas. In particular, in the embodiment of fig. 1-2-4, both the nares portion 20 and the mouth portion 40 are adapted to be connected with a source of pressurized breathable gas, such as a flexible tube 5, via an elbow 2, but only one portion may be connected. The flexible tube 5 may be connected to either or both of the nares portion 20 and the mouth portion 40. For example, the connection to both the nares portion 20 and the mouth portion 40 may be achieved by using a connector such as the double elbow 712 shown in fig. 34.
In the embodiment of fig. 1-2 and 2-4, the nares portion 20 and the mouth portion 40 are internally connected, allowing air to flow therebetween, such as by using a connector 30 in the nares portion that connects with an opening 46 in the mouth portion 40, although other connections may be used. If it is desired to prevent air flow between the nares portion 20 and the mouth portion 40, the connection may be blocked using a plug 35 or valve 55 actuated by knob 54.
The mask system 1 may be used wherein pressurized breathable gas is received by the patient's nares and mouth by either the swivel connector 4 connecting the elbow 2 and flexible tube 5 to the nares portion 20 or the swivel connector 44 of the mouth portion 40 and is able to flow through the connector 30 and the opening 46. The mask system 1 can also be used as a mouth seal or nares seal in which the connector 30 and/or opening 46 is blocked by using the plug 35 or by actuating a valve by the knob 54 and connecting only one of the nares portion 20 or mouth portion 40 with the elbow 2 and flexible tube 5. For example, if the elbow 2 and flexible tube 5 are connected with the nares portion 20 and the connector 30 and/or opening 46 are blocked by use of the plug 35 or by activation of the valve 55 by the knob 54, pressurized air is delivered to the nares portion 20 and the mouth portion 40 acts as a mouth seal that does not deliver pressurized air to the patient's mouth. Alternatively, if the elbow 2 and flexible tube 5 are connected to the mouth portion 40 and the connector 30 and/or opening 46 are blocked by use of the plug 35 or by activation of the valve 55 by the knob 54, pressurized air is delivered to the mouth portion 40 and the nares portion 20 acts as a nares seal that does not deliver pressurized air to the nares of the patient.
The mask system 1 is also adapted to function in a nares only mode using the nares portion 20 without the mouth portion 40, as shown in fig. 1-1. In this mode, the mouth portion 40 and headband 63 are not used, the plug 3 is removed from the nares portion 20, and the elbow 2 and flexible tube 5 are connected with the nares portion 20 to deliver pressurized breathable gas to the patient's nares. The connector 30 is plugged with a plug 35.
The mask system 1 is also adapted to function in a mouth-only mode using the mouth portion 40 without the nares portion 20, as shown in fig. 1-4. In this mode, the nares portion 20 and headgear 61 are not used, and the elbow 2 and flexible tube 5 are connected with the mouth portion 40 via swivel connector 44 to deliver pressurized breathable gas to the patient's mouth. The opening 46 in the mouth part is plugged with a plug 35.
Fig. 5-1 to 13 show another embodiment of a mask system 1 that may be a modular mask system. Fig. 5-1 and 6-13 show the modular mask system 1 in a nares and mouth mode. The flexible tube 5 is connected with the elbow 2 via the swivel ring 4 to direct pressurized breathable gas to the chamber of the mouth portion 40 and the nares portion 20 via the nares portion connector 43.
The decoupling portion 45 is connected between the swivel ring 4 and both the nares portion 20 and the mouth portion 40. Additionally, the nares portion 20 may also include a separation portion 25 such that the nares portion benefits from two separation portions to separate forces or motions applied to the flexible tube 5, the elbow 2, and/or the swivel ring 4 to prevent their transfer to the sealing portion 22 of the nares portion 20.
In the embodiment of fig. 5-1-13, the nares sealing portion 22 may be in the form of a nasal pillow, such as shown in fig. 8, 9, 11, and 12, or may be in the form of a prong, a membrane seal, such as a nasal cradle, and/or a nasal cavity. For example, the nares portion of figures 5-13 may be in the form of the nares portion 220 shown in figures 19 and 20. The support portion 252 may or may not be included. When the nares portion 220 is used, a sealing portion 222 that seals with the patient's nares is configured to extend or curve outwardly from the support wall 221 defining an air path through the sealing portion 222 and form a seal with the patient's nose tip, upper lip, and nares.
As shown in fig. 5-2, the mask system may be used in a nostril only mode. In this mode, the mask system may use the nares portion 20 and the patient does not use the mouth portion 40. To convert the mask system from the nares and mouth mode to the nares only mode, the swivel ring 4, elbow 2 and flexible tube 5 are removed from the mouth portion 40, the mouth portion 40 is removed from its connection with the nares portion 20 by disconnecting the nares portion connector 43 from the nares portion 20, and the swivel ring 4, elbow 2 and flexible tube 5 are connected with the nares portion. Although the headgear 60 shown is shown with the connection regions 67, the connection regions 67 may be omitted to facilitate use of the mask system 1 in a nares-only configuration without the lower headgear straps 63.
Fig. 21 and 22 show a mask system 301 according to an embodiment of the invention. The mask system 301 is adapted for use in a nares only mode, in a mouth only mode, or in a nares and mouth mode. The mask system 301 includes a nares portion 320, a mouth portion 340 and a headband 360, a connector 306, an optional swivel connector 308, and a flexible tube 305. The connector 306 may be in the form of a bent tube or other type of connector.
The nares portion 320 includes a nares sealing portion 322, a headgear connector 321 for connecting with headgear 360, a breakaway portion 325, and an opening 326. The nares sealing portion 322 may be in the form of a pillow, prong, nasal chamber, or membrane seal, and may be in the form of the nares sealing portion 222 shown in fig. 19 and 20. The mouth portion 340 includes a breakaway portion 345, an opening 348, and a connector 349. The connector 306 is adapted to connect with the opening 326 in the nares portion 320 or the opening 348 in the mouth portion 340.
As shown in fig. 21, the mask system 301 is adapted for use by a patient in a nostril only mode without the mouth portion 340. The connector 306 connects with an opening 326 in the nares portion 320. An optional swivel connector 308 may be used between connector 306 and flexible tube 305, with flexible tube 305 delivering pressurized breathable gas to nares portion 320.
As shown in fig. 22, the nostril only configuration in fig. 21 is convertible to a nostril and mouth configuration by removing the connector 306 from the opening 326 in the nostril portion 326, connecting the connector 349 of the mouth portion to the opening 326, and connecting the connector 306 to the opening 348 in the mouth portion 340. In the nares and mouth configuration, the nares portion may receive pressurized breathable gas through connector 349 and opening 326. Optionally, the nares portion 320 may be used as a nares seal by placing a plug into the connector 349 such that pressurized breathable gas is not delivered to the nares portion 320.
The mouth portion 340 may also be used in mouth-only configurations without the nares portion 320. In the mouth-only configuration, the nares portion 320 is not used and a plug is positioned in the connector 349 to provide a seal.
Fig. 24 shows a modular mask system 401 in accordance with an embodiment of the present invention. The mask system 401 includes a nares portion 420, a mouth portion 440, and headgear 460.
The nares portion 420 includes a nares sealing portion 422 for forming a seal with the nares of the patient and a headgear connector 421 adapted for connection with a headgear 460. The nares portion 420 is illustrated with a nares sealing portion 422 of the type shown in figures 19 and 20, but other nares sealing portions may be used, such as pillows, prongs, nasal chambers, and the like. An optional decoupling portion 425 may be included for decoupling any force applied to the nares portion 420. The headband 460 may be the same as the headband 60 shown in figures 1-1 through 4.
The mouth portion 440 includes a mouth sealing portion 442, a headband connector 441 for connecting with the headband 460, and a swivel connector 444. The mouth portion may also include an optional breakaway portion 445. Swivel connector 444 may be connected to elbow 402 and flexible tube 405, with elbow 402 and flexible tube 405 delivering pressurized breathable gas to mask system 401. The mask system 401 is optionally formed as a modular mask system in which the mouth portion 440 can be separated from the nares portion 420 and the two portions can be used separately, and the flexible tube 405 can be connected to the nares portion 420 via a swivel connector 444 or the like. Flexible portion 443 can be disposed between breakaway portion 425 and breakaway portion 445. The flexible portion 443 may be a gusset or collapsible portion between the mouth portion 440 and the nares portion 420, which allows the nares portion 420 to adopt the nasolabial angle (the angle between the septum and the upper lip of the patient's nose).
Fig. 25 shows a modular mask system 501 according to an embodiment of the invention. The mask system 501 includes a nares portion 520, a mouth portion 540, and headgear 560.
The nares portion 520 includes a nares sealing portion 522 adapted to form a seal with the nares of the patient, and a headgear connector 521 for connecting with a headgear 560. The nares portion 520 is illustrated with a nares sealing portion 522 of the type such as shown in fig. 19 and 20, but other nares sealing portions may be used, such as pillows, prongs, nasal cavities, and the like. An optional decoupling portion 525 may be included for decoupling any force applied to the nares portion 520. The headband 560 may be the same as the headband 60 shown in figures 1-1 through 4.
The mouth portion 540 includes a mouth seal portion 542, a headgear connector 541 for connecting with headgear 560, a swivel connector 544, and a foam seal or foam patient contact portion 569. The foam patient contacting portion 569 may be a wedge that serves as at least a portion of the mouth seal. The mouth portion 540 may also include an optional breakaway portion 545. Swivel connector 544 may be connected to elbow 502 and flexible tube 505, elbow 502 and flexible tube 505 delivering pressurized breathable gas to mask system 501. The mask system 501 is optionally formed as a unitary mask system, wherein the mouth portion 540 can be separated from the nares portion 520 and the two portions can be used separately, and the flexible tube 505 can be connected to the nares portion 420 via a swivel connector 544 or the like.
Fig. 34 shows another modular mask system 701. Mask system 701 includes a nares portion 720, a mouth portion 740, and a headgear 760. In this embodiment, the nares portion 720 is modular with the mouth portion 740 such that the nares portion 720 may be used in a first nares only mode without the mouth portion 740, the mouth portion 740 may be used in a second nares only mode without the nares portion, or the nares portion 720 may be used in a third nares and mouth mode with the mouth portion 740.
The nares portion 720 may include a sealing portion 722 adapted to form a seal with the nares of the patient, an optional breakaway portion 725, and a headgear connector 721 for connecting with a headgear 760. A swivel or other connector 710 may also be used. The sealing portion 722 may be in the form of a pillow, prong, nasal chamber, or a membrane-type nostril sealing portion such as shown in fig. 19 and 20.
The mouth portion 740 may include a mouth sealing portion 742, a separating portion 745, and a headgear connector 741 for connecting with the headgear 760. A rotating ring or other connector 744 may also be used.
In a mouth and nares mode such as that shown in fig. 34, both the nares portion 720 and the mouth portion 740 are used and connected to the flexible tube 705 by a double elbow 712. The double elbow 712 includes two elbow joints so that it may be connected to both the nares portion 720 and the mouth portion 740 to deliver pressurized breathable gas to the patient's nares and mouth. The nares portion 720 and the mouth portion 740 may or may not be pneumatically connected.
In the nostril only mode, only the nostril portion 720 is used and the mouth portion 740 is not used. In this mode, the double elbow 712 is removed and the mouth portion 740 is removed. The patient uses only the nares portion 720 and connects the tube 705 with a swivel or other connector 710. An elbow, such as elbow 2, may be used to connect the tube 705 with a swivel or other connector 710.
In the mouth-only mode, only the mouth portion 740 is used and the nares portion 720 is not used. In this mode, the double elbow 712 is removed and the nares portion 720 is removed. The patient uses only the mouth portion 740 and connects the tube 705 with a swivel or other connector 744. An elbow, such as elbow 2, may be used to connect tube 705 with swivel ring or other connector 744.
Fig. 26 shows a schematic cross-sectional view of the mask system 1 used in the nares and mouth mode. In this embodiment, the mouth portion 40 may include a sealing ring 51 adapted to connect and seal the mouth portion 40 with the nares portion 20. Alternatively, the sealing ring 51 may be formed as part of the nares portion 20 and connected and sealed with the mouth portion 40. Further, other types of connectors may be used, and the nares portion 20 and the mouth portion 40 may be formed as a unitary member, such that a gasket or other type of connector is not required.
In fig. 26, the flexible tube 5 is connected with the mouth portion 40 via the gusset 8 and optional inline AAV (anti-asphyxia valve) adapter 10, and the elbow 2 and swivel connector 4 are not used. This embodiment presents a very streamlined appearance by moving the flexible tube 5 away from the front of the patient's face.
Fig. 29-1 shows a schematic cross-sectional view of a mask system 401 used in a nares and mouth mode. The nares portion 420 may include a support portion 458 and a sealing portion 422. The sealing portion 422 includes a nose tip engagement portion 454 that engages and seals with the tip of the patient's nose, an upper lip engagement portion 456 that engages and seals with the upper lip area of the patient, and a sealing ring 472 that engages and seals with the mouth portion 440. The sealing ring 472 may alternatively be a component of the mouth portion 440 rather than the nares portion 420.
The mouth portion 440 may include a swivel 444, the swivel 444 being connected to the flexible tube 405. The flexible tube 405 may be connected directly to the swivel 444 or may be connected through an elbow, such as elbow 402. The mouth sealing portion 442 forms a seal around the patient's mouth and includes an upper lip engaging portion 448 that forms a seal with the upper lip area of the patient.
There is a limited amount of space on the patient's upper lip for the upper lip-engaging portion 456 of the nares portion 420 and for the upper lip-engaging portion 448 of the mouth portion. Thus, the upper lip engaging portion 448 may be disposed between the support portion 458 of the nares portion 420 and the patient's upper lip. Fig. 29-2 illustrates the mouth sealing portion 442 having an upper lip engaging portion 448. The upper lip-engaging portion 448 may be an ultra-thin flat film having a thickness of about 0.1mm to 0.3mm, preferably about 0.2mm, as compared to the rest of the mouth sealing portion 442 (which may have a thickness of about 0.3mm to 2mm, preferably about 0.5 mm). However, the portion of the mouth seal portion 442 may include thickened portions 409 around the sides of the mouth region corresponding to the cheek regions of the patient for enhanced support. These thickened regions 409 may have a thickness of, for example, about 1.5 mm.
Fig. 29-3 is a schematic cross-sectional view showing further details of the mask system 401. In particular, fig. 29-3 illustrate how the mouth sealing portion 442 extends around the patient's mouth and how the nostril flare (flare) engaging portion 427 engages the flare of the patient's nostril. Additionally, the rear edge of the nasal sealing region 470 is illustrated with the edge 472 of the nares sealing portion 422.
Fig. 30-1 shows a schematic cross-sectional view of a mask system 501 used in a nares and mouth mode. The nares portion 520 may include a support portion 558, a sealing portion 522, and an optional decoupling portion 525. The sealing portion 522 includes a nose tip engaging portion 554 that engages and seals with the tip of the patient's nose, and an upper lip engaging portion 556 that engages and seals with the upper lip area of the patient. A sealing ring 572, which engages and seals with the mouth portion 540, may be attached to the separate portion. The sealing ring 572 is optionally a component of the mouth portion 540, rather than the nares portion 520.
The mouth portion 540 may include optional cushion stiffeners 573 to increase the stiffness of the sealing portion 522. The cushion rigidizer 573 may be made of a polymer such as polycarbonate, nylon, polypropylene, high density foam, a fabric with low stretch properties similar to a 3D textile, or a higher shore hardness (e.g., 70 shore a) silicone or gel. There is a limited amount of space on the patient's upper lip for the upper lip engaging portion 556 of the nares portion and for the upper lip engaging portion of the mouth portion. Accordingly, the foam patient contacting portion 569 may be disposed in the gap between the cushion on the mouth portion 540 and the upper lip engaging portion 556. The foam patient contacting portion 569 may contact and form a seal with the upper lip area of the patient, forming part of the mouth seal.
Fig. 30-2 shows a schematic cross-sectional view of a mask system 501 used in a second nostril and mouth mode. The sealing ring 572 is formed as part of the mouth portion 540 and is adapted to engage and seal with the decoupling portion 525 of the nares portion 520. There is a limited amount of space on the patient's upper lip for the upper lip engaging portion 556 of the nares portion and for the upper lip engaging portion of the mouth portion. In this embodiment, the foam patient contacting portion 569 is disposed against the separating portion 525 and cushion on the mouth portion 540 and contacts and forms a seal with the upper lip area of the patient. The foam patient contacting portion 569 may form part of a mouth seal. The cushion rigidizer 573 of fig. 30-1 may also be used in the embodiment of fig. 30-2 and in any of the other embodiments disclosed herein.
Fig. 42 shows a schematic cross-sectional view of a mask system 1100 used in a nares and mouth mode. Mask system 1100 may be a variation of mask system 701 shown in fig. 34. The mask system 1100 includes a nares portion 1120, a mouth portion 1130, and a double elbow 1140. The lower end 1141 of the double elbow 1140 is adapted to connect with the swivel 1105, and the swivel 1105 may connect with a flexible tube to deliver air to the mask system 1100. The lower end 1141 may be connected to the rotary member 1105 by a ball and socket arrangement (as shown) adapted to provide a greater degree of movement of the rotary member and, therefore, the air delivery tube. Alternatively, the lower end 1141 may be coupled to the rotating member 1105 in any arrangement, such as an interference fit, overmolding, or the like.
The first air channel or branch 1146 of the double elbow 1140 is adapted to communicate with a hole in the mouth portion 1130 and the second air channel or branch 1148 of the double elbow 1140 is adapted to communicate with a hole in the nares portion 1120. A first elbow ring 1142 and a second elbow ring 1144 are used to connect the double elbow 1140 to the nares portion 1120 and the mouth portion 1130, respectively, although other types of connectors may be used. The double elbow may include barbed ends 1143 on the ends of the first and second branches 1146, 1148 to engage the mouth portion 1130 and the nares portion 1120.
The mouth portion 1130 includes a lower lip engaging portion 1134 adapted to form a seal under the patient's lower lip, and an upper lip engaging portion 1132 adapted to form a seal just above the patient's upper lip. The nares portion 1120 includes a nozzle 1122, the nozzle 1122 adapted to position the nares portion 1120 in close proximity to the patient's nares and to ensure that the foam portion 1154 is in sealing engagement with the patient's nares, although pillows, nasal chambers, nasal cradles (nares seals), or membrane seals may also be used to form a seal with the patient's nares.
The mouth portion 1130 may be a single wall or a fabric/foam composition mouth portion having a relatively low shore hardness. The nares portion 1120 may have a hardness of, for example, 40 shore a.
Fig. 43 shows a schematic cross-sectional view of a mask system 1100 used in a nares and mouth mode, and is the same as the mask system 1100 of fig. 42, with a different nares portion 1150. The nares portion 1150 includes a support portion 1153 that supports a nozzle 1152, and a foam portion 1154. The nozzle 1152 and foam portion 1154 together form a sealing portion adapted to form a seal with the nares of a patient. The nozzle 1152 may have an air passage that gradually decreases in size as the air approaches the patient's nares. Support portion 1153 may have a hardness of, for example, 40 shore a. The nozzles 1152 help to support the foam portions 1154 in position immediately adjacent the nares of the patient. Foam portion 1154 allows for a greater range of fit because of the compressibility of the foam which allows the foam to conform to a variety of nostril sizes. The foam portion 1154 also provides comfort to the patient.
Fig. 44 shows a schematic cross-sectional view of a mask system 1100 for use in a nares and mouth mode, with a nares portion 1160. The nares portion 1160 includes a support portion 1162 and a sealing portion 1164. The support portion 1162 may be constructed of silicone and serves as an intermediate portion or connecting portion between the double elbow 1140 and the sealing portion 1164.
The support portion 1162 positions the sealing portion 1164 below the user's nares and holds the sealing portion 1164 in this position. The support portion 1162 may include substantially parallel side portions and end portions 1165 formed substantially perpendicular to the side portions. The end 1165 provides an interface surface for the sealing portion 1164. The sealing portion 1164 may be constructed of foam, gel, or other conformable material. Preferably, the sealing portion 1164 is more flexible than the support portion 1162 to aid in the comfort and range of fit of the seal. The sealing portion 1164 may be a foam having holes that form a seal with the tip, upper lip, and nostrils of the patient. In an example, as shown in fig. 44A, the support portion may include a support wall 1162-1 (e.g., constructed of silicone or a material having a higher stiffness than the foam sealing portion) to prevent the foam from compressing and occluding the nostrils. In another example, as shown in fig. 44B, the foam sealing portion 1164 may have a flared shape (e.g., flared) with a silicone support wall underneath to ensure structural stability of the foam and also ensure a sealing engagement with the patient.
Fig. 45 shows a schematic cross-sectional view of a mask system 1100 used in a nares and mouth mode, with a nares portion 1170. The nares portion 1170 includes a support portion 1172 and a sealing portion 1174. The sealing portion 1174 includes a nose tip engagement portion 1176 and an upper lip engagement portion 1178. The support portion 1172 can form a seal just above the patient's upper lip and can be located between the patient's upper lip and the upper lip engaging portion 1132 of the mouth portion 1130.
The support portion 1172 may have a higher shore hardness than the seal portion 1174. For example, the support portion may have a shore a durometer of, for example, 20-80, preferably 30-60 or about 40, while the seal portion 1174 has a shore a durometer of about 5-40 or about 20. The sealing portion is typically less rigid than the support portion.
Fig. 46 shows a schematic cross-sectional view of a mask system 1180 used in a nares and mouth mode, having a mouth portion 1182 and a nares portion 1190. The nares portion 1190 is removable from the mask system 1180 and replaceable with a plug so that the mask system 1180 may be used in a mouth-only mode.
The mouth portion 1182 includes an aperture for connection with an air supply to deliver air to the mask system 1180. Elbow 1188 is connected to the bore via a seal 1189. Swivel 1187 may be connected between elbow 1188 and air hose 1185. A swivel cuff (not shown) may be connected between swivel 1187 and air hose 1185.
The mouth portion 1182 includes a lower lip engaging portion 1184 adapted to form a seal under the patient's lower lip, an upper lip engaging portion 1186 adapted to form a seal just above the patient's upper lip, and a dummy flap (vanity flap) covering the nares and/or nasal tip (primarily covering the nasal tip) or a cover sheet 1183 adapted to cover the patient's nares and nares portion 1190, making the mask system 1180 more attractive in appearance. Cover sheet 1183 extends upwardly a sufficient height to cover the patient's nostrils and nostril portions 1190.
The nares portion 1190 may include a support portion 1192 and a sealing portion 1193. The sealing portion includes a nose tip engagement portion 1194 and an upper lip engagement portion 1196. The nares portion 1190 may be connected via a mouth clip 1198 and a nares clip 1198.1 with an upper aperture in the mouth portion 1182 into which the nares portion 1190 may be placed. When the nares portion 1190 is not used in the mask system 1180, the nares portion 1190 is removed from the mouth clip 1198 and a plug may be placed in the mouth clip 1198 or in the hole to provide a seal. Mouth clip 1198 may be silicone or another material, such as nylon, polypropylene, or the like.
Fig. 47 shows a schematic cross-sectional view of a mask system 1200 used in a nares and mouth mode, having a mouth portion 1202 and a nares portion 1220. The nares portion 1220 can be removed from the mask system 1200 and replaced with a plug so that the mask system 1200 can be used in a mouth-only mode and the nares portion can be used in a nares-only mode.
The mouth portion 1202 includes a front 1204 or bandage, a lower lip engaging portion 1206, an upper lip engaging portion 1208, a nares portion tab 1210, a dummy tab or covering 1212, and a separating portion 1214. The front or bandage 1204 may be a large transparent window to allow visualization of the patient's mouth region. The nares portion tabs 1210 may be adapted to receive the nares portion 1220 and to sealingly engage the nares portion 1220.
The nares portion 1220 includes an attachment ring 1229 adapted for sealing engagement with the mouth portion 1202, a support portion 1222, and a sealing portion 1224. The attachment loop 1229 may be co-molded with the rest of the nares portion 1220, welded, permanently snapped on, or removably attached. The sealing portion 1224 includes a nose tip engagement portion 1228 adapted to form a seal with the tip of the patient's nose, and an upper lip engagement portion 1226 adapted to form a seal just above the patient's upper lip.
The covering sheet 1212 is positioned immediately adjacent the tip engagement portion 1228 of the nares portion 1220. Therefore, if the covering sheet 1212 moves, the nose tip-engaging portion 1228 also moves. Accordingly, the separating portion 1214 is included on the mouth portion 1202 at a position below the covering sheet 1212. The decoupling portion 1214 serves to decouple forces applied to the mouth portion 1202 (such as may be generated by forces applied by movement of the air hose 1232) from being transmitted to the nares portion 1220.
The mouth portion 1202 includes a lower aperture adapted to receive an elbow 1230, such as a gusset elbow, connected to an air delivery tube 1232. Gusset elbow 1230 may include an anti-asphyxia valve and/or one or more vents for venting exhaled gases. When in the nostril only mode, the tube may be connected to a nasal cushion or pillow.
Fig. 48 and 49 illustrate a modular mask system 1260 including a mouth portion 1262 and a nares portion 1280. The mask system 1260 is adapted for use in a mouth only mode, a nostril only mode, or a mouth and nostril mode.
The mouth portion 1262 includes a lower lip engaging portion 1264, an upper lip engaging portion 1266 adapted to urge the nasal seal into engagement with the face, a separating (concertina) portion 1270 and an aperture 1272. A hole (not shown) on the front or bottom of the mouth portion may be provided to connect with an air supply, such as an air hose connected by an elbow or the like. The flexible portion 1270 may be air actuated or may be a thinner wall (e.g., less rigid) and form a breakaway portion that separates forces applied to the mouth portion 1262 to prevent application to the nares portion 1280. When used in the mouth-only mode, the aperture 1272 may be plugged to provide an airtight seal.
The nares portion 1280 includes a support portion 1282, a sealing portion 1284, and a headgear connector 1290. The sealing portion 1284 is adapted to seal with the upper lip and tip of the nose of the patient. When used in the nostril only mode, the hole 1274 can be connected to an air source or plugged if air is selectively supplied. When used in the nares and mouth mode, the nares clip 1286 may be connected, preferably permanently connected, or otherwise formed into the support portion 1282 with the support portion 1282, and the mouth clip 1268 may be connected, preferably permanently connected, or otherwise formed into the cushion of the mouth portion 1262 with the mouth portion 1262. The nares clip 1286 and the mouth clip 1268 are adapted to be sealingly connected by, for example, a notch or the like formed in the clip, such that the mouth portion 1262 may be connected with the nares portion 1280 in the nares and mouth mode.
Fig. 54 shows a cross-sectional view of a modular mask system 1350, the modular mask system 1350 including a mouth portion 1352 and a nares portion 1360. The nares portion 1360 may be removable from the mask system 1350 and replaced with a plug such that the mask system 1350 may be used in a mouth-only mode, or the nares portion 1360 may be used in a nares-only mode.
The mouth portion includes a frame 1354 and a mouth seal 1355. First hole 1351 is positioned in frame 1354 adapted to receive elbow 1374 for delivery from an air hose via swivel 1376. A second hole 1357 is formed in the frame 1354, the second hole 1357 may be plugged when the mask system is used in the mouth only mode, and the second hole 1357 may be connected with the nares portion 1360 when the mask system 1350 is used in the nares and mouth modes.
The frame 1354 may be a rigid material, such as polycarbonate, or a semi-rigid material. The mouth seal 1355 may be a flexible material, such as silicone. The mouth seal 1355 includes a lower lip engaging portion 1356 adapted to form a seal under the patient's lower lip, and an upper lip engaging portion 1358 adapted to form a seal just above the patient's upper lip (when used in the mouth-only mode).
Nares portion 1360 includes a support portion 1362 and a sealing portion 1364. Sealing portion 1364 includes a nose tip engagement portion 1368 adapted to form a seal with the tip of the patient's nose and an upper lip engagement portion 1370 adapted to form a seal just above the patient's upper lip. The support portion 1362 may also form a seal just above the patient's upper lip. A collar 1359 may be used to connect the nares portion 1360 with the mouth portion 1352.
Fig. 60 shows a modular mask system 1430 that includes a mouth portion 1432 and a nares portion 1440. The mouth portion 1432 includes a cushion portion 1434 that is adapted to form a seal around the patient's mouth.
The nares portion 1440 includes a support portion 1446 and a sealing portion 1442. The sealing portion is adapted to form a seal with the patient's nares and includes a corner of a nose region 1447 and an upper lip engaging portion 1443.
The magnets 1436, 1448 may be placed over the mouth portion 1432 and the nares portion 1440 to ensure that the nares portion 1440 is properly oriented with respect to the mouth portion 1432. Either of the pair of magnets 1436, 1448 may be replaced with a metal portion. Magnets 1448 in the nares portion 1440 may be placed in the corners of the nose region 1447 to ensure adequate tightness of the nares seal over the patient's upper lip and corners of the nose.
Fig. 61 shows a cross-sectional view of a modular mask system 1480, which includes a mouth portion 1482 and a nares portion 1490. The nares portion 1490 is removable from the mask system 1480 and replaceable with a plug so that the mask system 1480 may be used in a mouth-only mode, or the nares portion 1490 may be used in a nares-only mode. Alternatively, the system may be used in a nares and mouth mode. In an example, separate foam members may be provided for the mouth and nares sealing portions so that the mask system may be used in a mouth only mode or a nares only mode.
The mouth portion 1482 includes a frame 1484 and a dummy or cover 1486, a lower aperture 1485 for connection of the spinner or cuff 1498 to the air hose 1499, and an upper aperture 1487 for connection of the nares portion 1490. The frame 1484 may be a rigid material, such as polycarbonate, or a semi-rigid material, such as semi-rigid nylon. The foam portion 1492 may have clips 1493 for attachment to the frame 1484.
The nares portion 1490 may include a flexible portion 1496, a foam portion 1492 that may be connected to the flexible portion 1496 by one or more clips 1493, and a nozzle portion 1494. The cover portions 1486 of the mouth portion 1482 may support the nares portion 1490. Alternatively, a permanent connection may be used, such as a foam portion directly connected to a flexible portion.
Fig. 61, 62, and 63 show a modular mask system 1500 that includes a mouth portion 1502 and a nares portion 1510. The nares portion 1510 can be removed from the mask system 1500 and replaced with a plug so that the mask system 1500 can be used in a mouth-only mode, or the nares portion 1510 can be used in a nares-only mode.
The mouth portion 1502 includes a frame 1504 and a dummy or cover sheet 1509, a lower hole 1505 for connecting to the elbow 1507, and an upper hole 1503 for connecting to the nares portion 1510. The frame 1504 may be a rigid material, such as polycarbonate, a semi-rigid or flexible material, such as nylon, silicone. The foam portion 1506 may have clips 1508 for attachment to the frame 1504.
The nares portion 1510 may include a flexible portion 1512, such as silicone, and a foam portion 1516 that may be coupled to the flexible portion 1512 by one or more clips 1514. The covered portion 1509 of the mouth portion 1502 may be spaced apart from the nares portion 1510. The clips 1508, 1514 may have a surface facing the foam portion that is angled to bias the foam portion or cause the foam portion to apply a force in certain directions (e.g., toward the lips of a patient).
Fig. 64 shows a modular mask system 1520 that includes a mouth portion 1522 and a nares portion 1540. The nares portion 1540 can be removed from the mask system 1520 and replaced with a plug so that the mask system 1520 can be used in a mouth-only mode, or the nares portion 1540 can be used in a nares-only mode. Alternatively, the system may be used in a mouth and nostril mode.
The mouth portion 1522 includes a frame 1523, a lower hole 1527 for connecting an elbow 1560 (which may include a vent 1562) and an air hose 1566, and an upper hole 1528 for connecting the nares portion 1540. Frame 1523 may be a rigid material, such as polycarbonate, or a more flexible material, such as silicone. The lower lip engagement portion 1524 is adapted to form a seal with the lower lip of the patient and the upper lip engagement portion 1526 is adapted to form a seal with the upper lip of the patient.
Nares portion 1540 includes a support portion 1542 and a sealing portion 1544. The sealing portion 1544 includes an upper lip engaging portion 1548 adapted to seal just above the patient's upper lip, and a nose tip engaging portion 1546 adapted to form a seal with the patient's nose tip or an area immediately adjacent to the nose tip. In the upper lip region, the support portion 1542 may be in contact with the upper lip engaging portion 1526 of the mouth portion 1522. When used in the nostril only mode, the hole 1528 may be connected to an air source or plugged if air is selectively supplied.
When used in a nares and mouth mode, the connecting loop 1550 may be used. The connection ring 1550 has a first passageway 1552 and a second passageway 1554. The first passageway 1552 is adapted to receive the mouth portion 1522 and the second passageway 1554 is adapted to receive the nares portion 1540.
Fig. 65 illustrates a modular mask system 1580 that includes a mouth portion 1582 and a nares portion 1590, the mouth portion 1582 and nares portion 1590 providing a soft-to-soft connection with the nose and mouth portions. The nares portion 1590 can be removed from the mask system 1580 and replaced with a plug so that the mask system 1580 can be used in a mouth only mode, or the nares portion 1590 can be used in a nares only mode.
The mouth portion 1582 includes a frame 1589, a lower aperture 1579 for attaching an elbow 1581, an air hose 1587, and an upper aperture 1577 for attaching a nares portion 1590. In an example, the elbow may include a button adapted to allow the elbow to be quickly released. Vent holes 1585 may be formed in the elbow 1581, such as via a vent ring interconnecting the elbow and the frame, or alternatively may be formed in the mouth portion 1582. The lower lip engagement portion 1584 is adapted to form a seal with the lower lip of the patient and the upper lip engagement portion 1586 is adapted to form a seal with the upper lip of the patient.
The nares portion 1590 includes a support portion 1592 and a sealing portion 1594. The sealing portion 1594 includes an upper lip engaging portion 1598 adapted to form a seal with the upper lip of the patient and a nasal tip engaging portion 1596 adapted to form a seal with the nasal tip of the patient.
The nares portion 1590 may have a recess 1595 adapted to form an interference fit with the mouth portion 1582. The nares portion 1590 may be resilient and pressed inward to receive the mouth portion in the recess and then snap back to its original shape. The "trumpet" shape on the mouth portion provides a lead-in to guide the nares portion into position. Also, a thin silicone wall may be provided to seal around the nares portion.
Fig. 66 shows a modular mask system 1600 that includes a mouth portion 1602, a nares portion 1610, an elbow and swivel 1612, an upper headgear 1618 with a rear strap 1619, and a lower headgear 1620 with a rear loop 1622.
The upper headgear 1618 is adapted to connect with the nares portion 1610 via a connector 1617, and the lower headgear 1620 is adapted to connect with the mouth portion 1602 via a connector 1615. The rear strap 1619 of the upper headband 1618 may be inserted through the rear ring 1622 of the lower headband 1620. Optionally, another strap may be connected from rear strap 1619 to rear ring 1622.
Fig. 67 shows a modular mask system 1630 that includes a mouth portion 1632, a nares portion 1640, an elbow 1644, and an air hose 1646. The mouth portion 1632 may have holes 1634 adapted to receive lugs disposed on the rear of the elbow 1644. In this manner, the nares portion 1644 can operate independently of the mouth portion 1632 or can be connected with the mouth portion 1632. In this example, the mouth portion may be connected to the nares portion and disconnected from the elbow.
Exemplary cushion 1
Fig. 68-73 illustrate a mask system 1650 having a mouth portion 1652 and a nares portion 1660. Figure 74 illustrates the nares portion 1660 and figure 75 illustrates the mouth portion, bandage or support structure 1652. Fig. 76-89 illustrate the cushion 1654 of the mouth portion 1652.
The mouth portion 1652 is removably detachable from the nares portion 1660, but the two portions may be co-molded. A seal 1665 (fig. 73) may be used to connect the mouth portion 1652 to the nares portion 1660. The hole 1656 is adapted to connect to an air supply to deliver air to the mask system 1650. The mouth portion includes a padded bandage portion 1657 (which may be transparent or semi-opaque), and a separation portion 1659, which separation portion 1659 may be a thinner portion than the remainder of the front of the mouth portion, to separate forces applied due to movement of an elbow/air hose connected to hole 1656 from the remainder of the mask system 1650.
A virtual plate or cover 1658 covers/supports the nostril area of the patient. Preferably, the virtual patch covers all or part of the nares sealing portion 1660. This arrangement may be less visually obtrusive to the patient and may help stabilize the nares sealing portion 1660.
Cushion 1654 is connected to cushion bandage portion 1657 and is adapted to form a seal around the patient's mouth. The connection of the cushion 1654 to the cushion bandage portion 1658 may be by means of an interference fit, such as a tongue.
A lower headgear connector (not shown) may be placed on the front of the mouth portion 1652 in the manner shown in fig. 24. The cushion 1654 and cushion bandage portion 1657 can each have a hardness of 40 shore a or the like. Optionally, the padded bandage portion 1657 can have a relatively higher durometer than the padding 1654. The padded bandage portion 1657 may be constructed from a semi-rigid polymer such as nylon, polycarbonate, polypropylene. The padded bandage portion 1657 can have a hardness of 40-80 shore a. The cushion 1654 may be constructed of a conformable material such as silicone, foam, gel, TPE. The cushion 1654 may be constructed of a material having a hardness of 5-40 shore a (e.g., 5-25 shore a).
The cushion 1654 may be constructed from a combination of materials, for example, a first portion proximate to the cushion bandage portion having a first durometer and a second portion proximate to the patient contacting portion having a second durometer. Preferably, the first stiffness is greater than the second stiffness to provide structural support to the patient contacting portion. For example, the first portion may have a hardness of 25-60 Shore A, 35-50 Shore A. The second portion may have a hardness of 5-25 shore a, 5-15 shore a. The first portion may be thicker than the second portion, for example, the first portion may be 1-3mm, 1-2mm, and the second portion may be 0.1-2mm, 0.1-1mm, or about 0.8 mm. The combination of the thin wall portion and the soft material at the second portion may allow the cushion to be more compliant and flexible to conform to the patient's face. The thicker first portion provides structure for providing stability. The first and second portions together allow for a single wall cushion that generally mimics a double wall cushion.
Preferably, the cushion 1654 may be flexible and/or may have a lower durometer (e.g., 5-15 shore a) in the chin region 1693 so that when the cushion is placed on the face of the user, the cushion stretches over the chin of the patient. The stretching of the cushion in chin region 1693 allows the cushion to be tensioned over the patient's chin, which can form a strong seal with the patient's chin while ensuring that the cushion can fit a wide range of chin geometries.
Cushion 1654 includes a cushion bandage connection portion 1655 (fig. 76) adapted to connect with cushion bandage 1657, a loop connection portion 1680, and a recess 1684. In the alternative, the cushion bandage and cushion may be formed as a unitary member. The loop attachment portion 1680 includes an aperture 1682 adapted to receive an attachment loop (to attach the mouth portion 1652 to the nares portion 1660). In the alternative, the loop connecting portion and the connecting loop may be formed as a unitary member. In another alternative, the cushion may be formed with a first connecting loop and the nares portion may be formed with a second connecting loop, the first connecting loop being received by the second connecting loop (or vice versa).
The recess 1684 is adapted and shaped to receive the gusset 1671 (fig. 74) of the nares portion 1660, or other portions of the nares portion 1660, such as a headgear connector portion of the nares portion 1660. If different nostril portions are used, different shaped recesses may be used. The recess 1684 is recessed within the cushion 1654 so as not to interfere with the sealing of the cushion 1654 when the nares portion 1660 is in the recess 1684. That is, the recess 1684 may be disposed or offset below or below an uppermost surface of the mouth cushion 1654 or below an uppermost surface of the mouth cushion 1654.
The recess 1684 can also be a depression, groove, channel, hollow, bladder, alcove, notch, depressed portion, dimple, depression, or indentation, i.e., a region of the cushion adapted to receive a nares portion, which has an alternating or abstract geometry when compared to the rest of the mouth cushion. The recess may not be a hole, cut-out or aperture. Preferably, the recess is airtight. Preferably, the pocket is formed from a soft, conformable material such as a mouth cushion rather than a frame. This arrangement is preferred because a conformal recess may allow for adjustment of the position of the nares portion, thereby fitting more patients. Preferably, the recess allows the nares portion to move in an up and down direction to accommodate different patient nose heights. Preferably, the rigidity of the recess may be increased when air pressure is applied, for example, in the mouth cushion. Preferably, the recess may stabilize the nares portion in place in a medial-lateral direction. This may be achieved by the shape of the recess being adapted to match the shape of the nares portion, this arrangement ensuring that the nares portion remains in sealing engagement with the patient's nares when tube drag or other forces are applied to the sides of the mask in use.
The nasal sealing portion may reside or rest in the pocket. The patient contacting portion of the nasal sealing portion may be positioned outside, above, or higher than the recess. This arrangement ensures that the patient can see the nasal seal portion in contact with their nose to ensure alignment and sealing.
In one form, the nasal seal portion may not be in airflow communication with the mouth portion via the recess.
The pocket may have a lower stiffness than the surrounding portions of the mouth cushion. The pocket may have a relatively thinner wall portion than other regions of the mouth cushion. The pocket may be formed from a different material than the remainder of the mouth cushion.
Preferably, the pocket is continuous with or formed as a unitary member with the upper lip contact region of the mouth cushion and is thus in sealing engagement with the upper lip of the patient.
The mouth cushion may include an upper lip region adapted to interface with the patient's upper lip. The mouth cushion may further include cheek regions adapted to interface with cheeks and/or sides of the mouth of the patient. The mouth cushion defines a wall between the patient contacting portion of the mouth cushion and the frame contacting portion of the mouth cushion. The wall may include different portions, for example, an upper lip wall portion, a chin wall portion, and two cheek wall portions, each of which corresponds to a respective upper lip, chin, and cheek region of the patient's face. In one form, the cheek walls may be relatively stiffer than the upper lip walls. In another form, the chin wall portion may be relatively stiffer than the upper lip wall portion. Preferably, the upper lip may be less stiff than the cheek walls. In this arrangement, the cheek contact portion may act compressibly on the patient's cheek so that the upper lip and chin region may be tensioned.
The recess 1684 in this example may include a curved slot having a lobe or region 1661 as shown in fig. 78. Lobe 1661 may be shaped to correspond to gusset 1671 as shown in fig. 74. The lobes may be separated by ridges or recesses 1663 adapted to indicate alignment or positioning of the nose 1660.
The recess 1684 may have a maximum width w1 of approximately 30-60 mm. Preferably, the recess 1684 may have a maximum width w1 of approximately 35-45 mm. Preferably, the recess 1684 may have a maximum width w1 of approximately 40-45 mm.
The recess 1684 can have a length d5 of about 15-40mm as shown in FIG. 85. Preferably, the recess 1684 has a length d5 of about 20-30 mm. This length may be the approximate length from the bandage contacting side of the recess to the outermost edge of lobe 1661.
The lobes 1661 of the recesses 1684 may be offset or angled relative to one another to position the nasal seal in an angled region of the maxilla (patient's upper lip). The lobes 1661 of the recesses 1684 may be angled relative to one another at an angle α 1 of approximately 90-180. The lobes 1661 of the recesses 1684 may be angled relative to one another at an angle α 1 of approximately 90-150. The lobes 1661 of the recesses 1684 may be angled relative to one another at an angle α 1 of approximately 90-180. The lobes 1661 of the recesses 1684 may be angled relative to one another at an angle α 1 of approximately 90-150.
The chin or lower seal region 1693 of the mouth cushion 1654 may be rounded or curved to conform to the patient's chin. The radius of curvature r1 may preferably be 20-50 mm. The radius of curvature r1 may preferably be 30-40 mm. The radius of curvature r1 may preferably be 35-45 mm.
The nostril portions may be secured to the cushion 1654 by connection with a connecting loop. The cushion can also have a thickened portion 1686 (fig. 80 and 81) to support a connection with the cushion bandage portion 1657. Also, the thickened portions 1686 support the sealing portion in place and prevent collapse of the sealing portion, particularly when the sealing portion is constructed of a low durometer, low thickness material, i.e., when the sealing portion lacks structural rigidity.
The nares portion 1660 includes a sealing portion 1662 adapted to form a seal with the nares of the patient, and a headgear connector 1670 for connecting with headgear. The sealing portion 1662 may be in the form of a nozzle, but other sealing portions may be used, such as pillows, prongs, and the like. Exemplary sealing portions are disclosed in WO 2009/052560a1, the disclosure of which is incorporated herein by reference in its entirety.
The cross-sections shown in fig. 82-84 are shaped to accommodate the flat face of the patient as well as the sharper face due to the question mark-like shape of the cross-section. Fig. 83 shows a cross section in the horizontal plane, which may be positioned substantially on the cheek or on the lateral extent of the patient's mouth. In this region, the cross-section of the cushion shows that the film is relatively longer than the thin upper or lower jaw region (shown in fig. 82 and 84). This may reduce the force of the cushion on the patient's cheek as compared to the thin upper and lower jaw regions, as a longer membrane may absorb more force than a shorter membrane. This may be because the patient's cheeks are more sensitive than the dry and thin areas of the face. The cushion is shaped to match the shape of the face, as shown in fig. 79, for example, in a C-shape. As shown, the sealing membrane includes a variable thickness along its length, e.g., from thick to thin. The variable thickness may also allow the patient contacting portion to be supported and positioned by the thicker regions, and the patient contacting region may be more comfortable and compliant due to the thinner regions. The patient contacting portion may be approximately 0.2-2 mm. Preferably, the patient contacting portion may be approximately 0.8-1.2 mm. The thicker region 1686 may be approximately 0.5-4 mm. Preferably, the thicker region 1686 may be approximately 2-3 mm.
In another example, the load transferred by the cushion to the user's face in the upper lip region 1692 may be greater than the load transferred by the cushion to the user's face in the chin region 1693. This may be accomplished by having a relatively greater thickness in the upper lip region 1692 as compared to the thickness of the chin region 1693. This arrangement may help anchor the cushion on the patient's face while ensuring that the forces on the chin are low. A greater force on the chin may force the upper airway to collapse and thus exacerbate obstructive sleep apnea, so it is desirable to have a lesser force on the patient's chin and thus on the chin region 1693.
The recess 1684 is configured to accommodate a nares portion within which air ensures a seal across the upper lip. The nested nares portion and cushion make the mask less obtrusive. The recess 1684 may have a depth d1 of approximately 5-30 mm. Preferably, the recess 1684 may have a depth d1 of approximately 5-20 mm. Preferably, the recess 1684 may have a depth d1 of approximately 5-10 mm. The depth d1 of the recess can be seen in fig. 80-81.
As best shown in FIG. 80, the recess 1684 may be adjacent to or connected to the sheet seal portion in the upper lip area 1692. A ridge or point 1694 can be formed between the recess 1684 and the upper lip area 1692. Ridges 1694 may be used to separate the pocket from the upper lip area and may also provide a hinge point or spring point for the upper lip area.
As best shown in fig. 80-81, the recess 1684 may be generally curved or rounded in a cup-like shape as shown at c 1.
In the chin region 1693, as best shown in fig. 80, the cushion may have a depth d2 of approximately 0.5-3mm, i.e., the distance from the sealing or patient contacting portion of the chin region to the connecting region 1655. The depth d2 may be approximately 1-2mm, preferably the depth d2 may be approximately 1.5-2 mm. This depth is desirable to ensure that the mouth cushion 1654 can accommodate a differently shaped chin. The chin lip region 1693 as shown in FIG. 85 demonstrates the depth d 4. Depth d4 may be substantially similar to depth d 1.
The cushion 1654 may have cheek regions 1695 and the cushion at the cheek regions 1695 may have a depth d2 as shown on fig. 82, 83, and 84. The depth d2 may be greater than d1, d 4. This arrangement may be preferred so that the cushion 1654 may flex and deform at the cheeks to a greater extent than at the upper lip, anchoring the cushion on the upper lip and accommodating changes in the geometry of the patient's face. For example, some patients may have a relatively flat face, while others may have a relatively sharp face, and therefore the cushion should be able to conform to each of these facial contours. For example, the depth d2 may be approximately 10-50 mm. Preferably, the depth d2 may be approximately 20-35 mm. Preferably, the depth d2 may be approximately 20-30 mm.
The curvature of the upper lip region 1692 of the cushion ensures tension across the patient's upper lip and therefore ensures a seal. The spring-shaped cross section at the upper lip reduces the displacement of forces at the patient's upper lip (sensitive area).
Fig. 86 shows the mouth cushion 1654 as viewed from the patient contacting side. Upper lip region 1692 has a height d6, d6 may be less than the height d7 of chin region 1693. This may be because a person's face typically has a small distance between the upper lip and the bottom of the nose (compared to the distance between the lower lip and the tip of the chin). For example, the height d6 may be 5-15 mm. Preferably, the height d6 may be approximately 8-10 mm. The height d7 may be approximately 10-25 mm. Preferably, the height d7 may be approximately 12-16 mm.
Exemplary cushion 2
Fig. 92A-92E and 93A-93I illustrate a variant of the mouth cushion 2100 that is similar to the example shown in fig. 76-89 and shares the following common features: such as a recess adapted to receive the nasal sealing portion and a single-sided wall 2104 that is thicker at its base where it is connected to the bandage and thinner at its distal end where it seals with the patient. The side walls have a sickle or question mark type shape.
Mouth cushion 2100 may have a top lip region 2692, chin region 2693, and cheek regions 2695. The mouth cushion may further include an attachment region 2655 for interfacing the mouth cushion with a clip, frame or other portion of the mask assembly.
The top lip region 2692 and chin region 2693 of the sealing portion are formed generally flat such that the seal stretches (by tensioning) over the patient's face to enhance the seal. This is beneficial because the headband, even when tightened, does not significantly alter the sealing force in this area.
The pocket 2102 is thin as compared to the pocket 1684 in FIG. 76. This allows the nasal seal to more directly increase some component of the sealing force, i.e., as the nasal seal is pressurized, the nasal seal may become stiffer and thus transfer force to the upper lip seal portion. The reduction in thickness may also reduce weight and/or material.
In addition, the cushion 2100 does not have a loop attachment portion 1680 as in fig. 86-89 (for example). Thus, the air flow reaching the nasal sealing portion is not transmitted through the mouth cushion. Instead, clips adapted to receive both the mouth cushion and the arm cushion may be provided, and passageways may be provided to deliver air to the nose cushion.
The pocket 2102 may not be cup-shaped, but instead has an opening that curves rearward and upward (see c2 shown on fig. 93D and 93E) to the ridge 2694 for subsequent abutment with the upper lip portion 2692.
The pocket 2102 can have a depth similar to the pocket 1684, as shown at depth E1 on fig. 93D and 93E. Depth e3 may also be similar to depth d3, depth e4 may be similar to depth e4, and length e5 may be similar to length e 5.
The depth e2 as shown on fig. 93D shows the distance from the edge or connecting region to the patient contacting portion. The depth e2 may be about 10-30mm, preferably 15-25 mm. The radius of curvature r2 may be larger than the radius of curvature r1 in example 1. This depth and radius of curvature r2 may ensure that the depth at chin region 2693 is similar to the depth at cheek region 2695. This may flatten out the cushion in the chin region so that when the patient positions their chin relative to the chin region 2693, the membrane stretches over their chin. This may ensure a more robust seal and a greater range of fit.
The width w2 as shown on fig. 93A may be larger than the width w 1. This may accommodate a longer nasal seal portion or move the same nasal seal portion of example 1 further down to the mouth seal portion 2100 (i.e., the nasal seal is farther from the top surface or deeper in the mouth cushion 2100). The width w2 may be approximately 50-70 mm. Preferably, the width w2 may be approximately 50-60 mm.
Exemplary cushion 3
Referring to fig. 104-131, a mask system 400 according to an embodiment of the invention includes a mouth cushion 4100, a cushion clip 4200, and a bandage 4300. The mouth cushion 4100 shares some common features with the example cushion 2, such as a pocket 4102 adapted to receive a nasal sealing portion and a sealing portion 4106 configured to form a seal with the patient's face. Other common features may be apparent from the following description of the mask system 4000. The mouth cushion 4100 may be formed of, for example, silicone. The cushion clip 4200 may be formed from, for example, a thermoplastic material. Bandage 4300 may be formed of, for example, a thermoplastic material.
The mouth cushion 4100 may be overmolded onto the cushion clip 4200. It should be appreciated that the mouth cushion 4100 may be removably attached to the cushion clip 4200 in the following manner. The mouth cushion 4100 includes a recess 4012, an upper connecting portion 4104, the upper connecting portion 4104 adapted to receive the nasal seal connecting portion 4202 of the cushion clip 4200 and retain the mouth cushion 5100 to the bandage 4300. Referring to, for example, fig. 117, the upper connecting portion 4104 is tilted or offset away from the sealing portion 4106 to allow the nasal sealing portion (not shown) to be oriented toward the patient's nasolabial angle. Referring to, for example, fig. 104, 112, and 113, the rear edge 4108 of the pocket 4102 and the upper connecting portion 4104 form an aperture 4110 that receives the nasal seal connecting portion 4202 of the cushion clip 4200. The nasal seal connection portion 4202 of the cushion clip 4200 fits within the aperture 4110 of the upper connection portion 4104 and the rear edge 4108 of the pocket 4102.
Referring to, for example, fig. 120-124, the mouth cushion 4100 includes a groove 4114 configured to receive the cushion clip 4200. The groove 4114 almost completely surrounds the cushion clip 4200. A small gap is provided in the groove 4114 to allow the tab 4218 (fig. 139) of the cushion clip 4200 to extend outward and engage and interlock with the slot 4310 (fig. 134, 135, and 138) of the bandage 4300. The mouth cushion 4100 further includes a lip seal 4112 interfacing with the groove 4302 (fig. 104, 109 and 111, and 138) of the fascia 4300 formed by the flap 4304. As shown, for example, in fig. 110 and 111, the lip seal 4112 is shown overlapping the tab 4304 of the groove 4302 of the bandage 4300. However, it will be appreciated that in the assembled state, the relatively flexible lip seal 4112 will deform and bend into the groove 4302 and be retained by the tab 4304 of the fascia 4300.
Referring to fig. 125 and 131, the cushion clip 4200 includes an adapter 4204 that receives a collar (not shown) of the nasal sealing portion. The adapter 4204 includes a relief 4206, the relief 4206 allowing the adapter 4204 and the tab 4208 to flex to retain the collar of the nasal seal portion. The cushion clip 4200 further includes a support region or portion 4210 on the lower corners of the clip 4200 to increase stability and force on the cushion 4100 in the cheek regions of the patient to provide a more secure seal over soft regions of the patient's face. The support regions 4210 on the lower corners of the clip 4200 may be thicker or stiffer than adjacent portions of the cushion clip 4200. The bandage contact lip 4212 is arranged to engage the groove 4302 of the bandage 4300. A cushion contact lip 4214 is provided to engage the groove 4114 of the mouth cushion 4100.
Referring to FIG. 132 and 145, bandage 4300 includes a lower headgear connector 4306 for connecting with a headgear, and an elbow connector 4308 for connecting with an elbow adapted to connect to a gas delivery tube or conduit. The rear surface of the fascia 4300 includes a groove 4302 (fig. 138) adapted to engage a flexible lip seal 4112 of the mouth cushion 4100. The rear surface also includes a slot 4310 configured to receive the flap 4218 of the cushion clip 4200 and interlock with the flap 4218 of the cushion clip 4200. As shown in fig. 138 and 145, the tabs 4218 are rounded to smoothly guide the tabs 4218 into the slot 4310 of the bandage 4300. The flaps 4218 may also be radiused to connect the upper flap adjacent adapter 4204 first and at a first position, then the cushion clip can be rotated to position the upper flap to a second position that allows the lower flap adjacent lower headgear connector 4310 (in use) to engage with the bandage 4300.
1.8 interface of cushion and bandage
Fig. 94-102 illustrate examples of the interface of the cushion and bandage. Fig. 94 and 95 show the mask assembly in its assembled state, including the pillow 3000, the mouth cushion subassembly 3002, and the elbow 3004. Fig. 96 shows an exploded view thereof.
Fig. 97 is an exploded view of subassembly 3002, including cushion 3006 and fascia 3008. The cushion 3006 includes clips 3010, and the clips 3010 may be overmolded onto the cushion. The cushion 3006 may be removably connected to the clip 3100.
The clip 3010 may have an adapter 3012 for attachment with the pillow 3000. The adapter 3012 may include a relief 3013, the relief 3013 allowing the adapter 3012 to flex inward and thus receive the nasal seal portion. The adapter 3012 may also include a tab 3014, the tab 3014 being adapted to lock or hold the position of the nasal seal portions after they are connected. The adapters 3012 may be angled in such a way as to present a nasal sealing portion directly towards the patient's nares. For example, fig. 94 and 95 show the nasal sealing portion 3000 oriented proximate to the patient's nasolabial angle.
The clip may be more rigid than the cushion and may be made of thermoplastic polyester elastomer (Hytrel), polypropylene, nylon, injection molded plastic, and the like.
Fig. 98A shows the patient side of fascia 3008. Fascia 3008 may include a recess 3008.1 at the top of the fascia and a recess 3008.2 at the lower side corner of the fascia. Fascia 3008 may further include a tab or ridge 3008.3 adapted to align and/or locate the mouth seal portion and/or clip. The outer or non-patient contacting side of fascia 3008 may be curved or stepped such that the middle portion is raised relative to the side portions. This may assist the patient in picking up the bandage when gripping onto the curved region. These curved regions may further include a gripping portion (not shown), such as a dimple or an overmolded button to assist the patient in gripping the bandage.
Fig. 97 is another exploded view showing that the fascia 3008 and retention clip 3010 can be clamped together at multiple locations (e.g., two or more locations, and in this example three locations). As shown in fig. 98A, 98B, and 99, fascia 3008 may have recesses 3008.1 that receive protrusions 3010.1 of clip 3010. Fig. 100-102 illustrate an exemplary sequence of adapting components between sub-components 3002. Fig. 100 shows the initial engagement between the mask top protrusion 3010.1 and the depression 3008.1, after which the mask pivots, as shown in fig. 101. Once the lower end of the clip is about to the lower portion of fascia 3008, the clip snaps back into place to complete assembly.
The clip may include an integral (silicone) lip seal to prevent leakage between the clip and fascia 3008. This will make the assembly more robust and less dependent on tolerances to prevent leakage. The lip seals may be positioned in close proximity to the protrusions 3010.1 or 3010.2. Fig. 103 illustrates an example of a lip seal 3011 that may be used in this assembly.
1.9 Integrated mask System
Fig. 14 and 15 show another mask system 101, which is an integrated mask system. The mask system 101 includes a nares portion 120, a mouth portion 140, and a flexible tube 105 connected to the mouth portion 140 via an elbow 102.
The nares portion 120 may employ a nares sealing portion 122, and the nares sealing portion 122 may be in the form of a nasal pillow, nasal prongs, a membrane seal such as a nasal cradle, and/or a nasal cavity. The nares sealing portion 122 may be in the form of a nares sealing portion 222 as shown in figures 19 and 20. The nares portion 120 may further include a breakaway portion 125 and a headgear connector 121 adapted to connect with a headgear 160.
The mouth portion 140 may include a structural portion 147, a mouth seal portion 142, a breakaway portion 145, a headgear connector 141, and a vent 103, which vent 103 may include one or more vent holes or slots for venting gases exhaled by the patient. When the nares portion 120 and the mouth portion 140 are not formed as a unitary member, a nares portion connector 143 adapted to connect with the nares portion 120 may be used. The mask system 101 may optionally be formed as a modular mask system in which the nares portion 120 and the mouth portion 140 are separable and may be used separately, and the nares portion 120 is connectable with the flexible tube 105 via the elbow 102.
Fig. 16-18 illustrate another mask system 201 that includes a nares portion 220 and a mouth portion 240. The nares portion 220 may include a nares sealing portion 222, an orifice 226 for receiving pressurized breathable gas. The mask system 201 is illustrated with a nares sealing portion 222 such as that shown in fig. 19 and 20, but other nares sealing portions may be used, such as pillows, prongs, nasal cavities, and the like.
The mouth portion 240 includes: a mouth sealing portion 242, which may be in the form of a cushion for sealing with the mouth of the patient; a frame 247; a mouth orifice 246 for receiving pressurized breathable air; a separation portion 245; and a nostril connecting portion 243 for connecting with the nostril portion. Fig. 16 illustrates the frame 247, the separating portion 245, and the connecting portion 243 removed. Although not shown, the mouth portion 240 may include a connection to a flexible tube for delivering pressurized breathable gas, such as the swivel connector, elbow, and flexible tube shown in other embodiments.
The mask system 201 may optionally be formed as a modular mask system in which the nares portion 220 and the mouth portion 240 are separable and may be used separately, and the nares portion 220 is connectable with the flexible tube 105 via the elbow 202.
Fig. 23 shows a mask system 370, which may include a nares portion 372, a mouth portion 380, and headgear 360. In this embodiment, the mask system 370 may have an integral nares portion 372 and mouth portion 380. The lower headgear bandage 379 passes under the patient's ear and provides a normal headgear vector force or sealing force on the patient's face. The headgear straps 360 provide support to assist in positioning and stabilizing the mouth portion 380 on the patient's face. Headgear straps 360 are not attached near the patient's mouth to keep the prominence of the mask to a minimum.
The nares portion 372 may include a nares sealing portion 374 and a mouth sealing portion 375. May comprise a separate portion.
Fig. 27 shows a schematic cross-sectional view of the integrated mask system 201 in which the nares portion 220 and the mouth portion 240 are formed as a unitary member. A decoupling portion 245 is formed in the mouth portion 240 and can decouple forces applied to the mask system (such as from a flexible supply tube) from the mouth portion 240. The nares sealing portion 222 is a nares sealing portion such as shown in figures 19 and 20. The nose tip engaging portion 254 seals with the tip of the patient's nose and the upper lip engaging portion seals with the upper lip of the patient. The schematic cross-sectional view omits the connection to the flexible tube.
Fig. 28 shows a schematic cross-sectional view of the integrated mask system 101 in which the nares portion 120 and the mouth portion 140 are formed as a unitary member. The schematic cross-sectional view omits the connection with the flexible tube 105. In this embodiment, the mouth seal portion 142 extends from the mouth portion 140, wherein the mouth seal portion 142 seals with the region between the patient's lower lip and the patient's chin, and from the nares portion 120, wherein the mouth seal portion 142 seals with the patient's upper lip region. The separation portion may be formed in the mouth portion 140 and may separate forces applied to the mask system (such as from the flexible supply tube) from the mouth portion 140.
Figure 31 shows a schematic cross-sectional view of an integrated mask system 370 in which nares portion 372 and mouth portion 380 are formed as a unitary member. The nares portion 372 includes a nares sealing portion 374 that forms a seal with the patient's nares and a mouth sealing portion 375 that forms a seal with the patient's mouth. A gusset 376 may be provided to connect the mouth portion 380 with the flexible tube 305. The gusset 376 may be used to separate movement of the flexible tube 305 from breaking the seal of the mouth portion 380 and/or nares portion 372.
Fig. 50-52 illustrate an integrated mask system 1300. The mask system 1300 includes a mouth portion 1302 and a nares portion 1310. The mouth seal of the mouth portion 1302 is oriented generally horizontally and the nares portion 1310 is oriented generally vertically to anatomically match the patient's mouth and nares. A gas washout vent may also be included.
The mouth portion 1302 includes a lower lip engaging portion 1304 adapted to form a seal with the lower lip of the patient, an upper lip engaging portion 1306 adapted to form a seal with the upper lip of the patient, and a bore adapted to receive pressurized air from an air supply hose 1318. Elbows and/or swivels may be used in conjunction with the air supply hose 1318.
The nares portion 1310 includes a nares engaging portion 1314 adapted to form a seal with the patient's upper lip, a nose tip engaging portion 1312 adapted to form a seal with the patient's nose tip, and a concertina or breakaway portion 1316 (see, e.g., fig. 50). The concertina portion 1316 decouples forces applied to the mouth portion 1302 from being applied to the nares portion 1310. The concertina section may also be filled with air and air pressure used to increase the force and thus provide a more secure seal.
Fig. 53 illustrates an integrated mask system 1320. The mask system 1320 includes a mouth portion 1322 and a nares portion 1330.
The mouth portion 1322 includes a lower lip engaging portion 1324 adapted to form a seal with the lower lip of the patient and a frame 1326. The frame 1326 may be a rigid material, such as polycarbonate. The lower lip engaging portion 1324 may be co-molded with the frame 1326.
The nares portion 1330 may include a support portion 1332, a sealing portion 1334, and a clip portion 1338 adapted to engage the sealing portion 1334 with the support portion 1332. Support section 1332 may be a semi-rigid material, such as nylon. Clip portion 1338 may be a semi-rigid material, such as nylon or polypropylene.
The sealing portion 1334 includes an upper lip engaging portion 1337 adapted to form a seal with the upper lip of the patient, and a nasal tip engaging portion 1336 adapted to form a seal with the nasal tip of the patient. Sealing portion 1334 may be a flexible material, such as silicone. The sealing portion 1334 may be co-molded with the frame 1326 as a unitary member.
An air supply hose 1344 may be connected to the mouth portion 1322 via a swivel 1342. The rotating member 1342 may be a rigid material such as polycarbonate.
Fig. 57 shows a modular mask system 1400, and fig. 58 and 59 show a related integrated mask system (which may be modular). The mask system 1400 includes a mouth portion 1402 and a nares portion 1410. An elbow 1407 connects an air supply hose 1409 with the mouth portion 1402 to deliver air to the mask system 1400. Headgear 1420 is connected with the mask system 1400 to secure the mask system 1400 to the head of the patient.
The mouth portion 1402 includes a front 1404 and a lower foam portion 1405. The lower foam portion 1405 is positioned to form a seal between the patient's lower lip/chin and the mouth portion 1402. The front 1404 may be a transparent portion that allows visualization of the patient's mouth area. The front 1404 may be, for example, silicone.
The nares portion 1410 may include a support portion 1412 and a sealing portion 1414. The sealing portion 1414 may include a nose tip engagement portion 1416 adapted to form a seal with the tip of the patient's nose, and an upper lip engagement portion 1418 adapted to form a seal with the upper lip of the patient. The support portion 1412 may also form a seal with the upper lip of the patient. The upper foam portion 1406 may be disposed between the nares portion 1410 and the patient's upper lip to provide additional comfort. The outer foam portion 1408 may be disposed between the front portion 1404 and the nares portion 1410. Upper foam portion 1406 and outer foam portion 1408 may be a single piece of foam, such as a ring-shaped piece of foam, with holes formed in the foam for insertion of nares portion 1410.
1.10 external member
The various components of the disclosed mask system may be used in one or more kits provided. For example, figure 33 illustrates a nostril-only kit 805 provided in accordance with an embodiment of the present invention. The nares-only kit 805 may include a nares portion 820 adapted to seal with and provide respiratory therapy to the nares of the patient and nares portion headgear 812. The nares-only kit may optionally include an elbow or other connector 802 that connects the nares portion 820 with a supply of pressurized air, although such an elbow or other connector 802 may be provided as part of the nares portion 820. The nares portion 820 may include the plug 35 of the embodiment of figures 1-4. However, the nares-only kit 805 may be provided with a commercially available mask, such as the Swift FX mask. If used with the mouth portion 840, the plug 35 may be removed.
The nares-only kit 805 is adapted to provide respiratory therapy to a patient's nares. This form of respiratory therapy, which is provided only to the nares, is preferred because it is less obtrusive to wear and is more comfortable for the patient, who in many cases only requires nares therapy. However, some patients may require oral therapy, either mouth only therapy or mouth and nostril therapy. For example, some patients breathing orally require a mouth portion to provide a mouth seal so that effective therapy can be applied to the nares. Other patients may require mouth only therapy or mouth and nostril therapy.
Thus, the mouthpiece 810 may be provided to patients requiring mouth only therapy, or patients requiring mouth and nostril therapy but already having a nostril only device or nostril only kit 805. The mouth set 810 may include a mouth portion 840 adapted to seal with and provide respiratory therapy to the patient's mouth, and mouth portion headgear 850. The mouth portion 840 may be adapted to provide respiratory therapy only to the mouth of the patient. If such a connector is not incorporated into the mouth portion 840, the mouth piece assembly 810 optionally includes an elbow or other connector 802 that can connect the mouth portion 840 with a supply of pressurized air.
The mouth portion 840 is optionally adapted to pneumatically interface with the nares portion 820 or another nares-only CPAP device. For example, the mouth portion 840 may include the hole 46 shown in figures 1-5 adapted to connect with a nares portion, in which case a plug 35 may also be provided in the mouthpiece 810 to plug the hole 46. The mouth portion 840 also optionally includes a valve 55 for selectively closing the aperture 46. Further, the mouthpiece 810 is optionally provided with a plug 803, the plug 803 being operable to plug a hole in the front of the mouth portion 840, and optionally with a double elbow 855, the double elbow 855 being operable to connect the mouth portion 840 and nares portion 820 with a supply of pressurized air. The mouth portion 840 may be used as a docking interface, wherein the mouth portion 840 is adapted to interface with the nares portion 820.
The mouth kit 810 is also optionally provided with a nares and mouth portion headband 860, the nares and mouth portion headband 860 including a connection region in the rear, such as the connection region 67 shown in fig. 7. A nares and mouth portion headband 860 may be used in place of the nares and mouth portion headband 812, 850. In addition, the mouth kit 810 is optionally provided with a connected nares and mouth portion headband 870, the nares and mouth portion headband 870 including a connector 856 for connecting the nares only headband and the mouth only headband in the rear.
The nares-only kit 805 may be used as a retrofit kit for a patient having a mouth piece kit 810 or other mouth piece that requires conversion of his mouth-only device to a mouth and nares device. In this case, the nares only kit is optionally provided with a double elbow connector 855, a plug 803, a nares and mouth part headband 860 or a connected nares and mouth part headband 870. Likewise, the mouthpiece 810 may be provided as a retrofit kit to a patient having a nares-only kit 805 or other nares portion that requires conversion of his nares-only device into nares and a mouthpiece.
The patient may use the nares-only kit 805 and/or the mouth kit 810 to convert the nares-only CPAP device 805 into a nares and mouth CPAP device in a variety of ways. The patient may remove the elbow or other connector from the nares portion 820 and connect the double elbow connector 855 to both the nares portion 820 and the mouth portion 840 so that air is delivered to both the nares portion 820 and the mouth portion 840 through the double elbow connector 855. The patient may use the original nares partial headgear 812 on the nares portion and the mouth partial headgear 850 on the mouth portion 840. Connectors 856 are optionally used to connect the nares portion headband 812 with the mouth portion headband 850. Optionally, a nares and mouth portion headband 860 may be provided to connect the nares portion 820 with the mouth portion 840. The nares and mouth portion headgear 860 may be connected in the rear portion, for example, by using connection regions 67 or a uniform strap as shown in figure 7. If the nares portion 820 is provided with structure adapted to connect with a mouth portion (e.g., the connector 30 shown in figures 1-5), the mouth portion 840 provided in the mouthpiece 810 may include structure to connect the nares portion 820 with the mouth portion 840, such as the opening 46 shown in figure 5-1. A valve 55 and knob 54 may also be provided.
In embodiments including structures that allow for pneumatic connection between the nares portion 820 and the mouth portion 840, such as the connector 30 and the opening 46, the patient may connect the connector 30 with the opening 46 and deliver air to the patient's nares and to the patient's mouth using the elbow or other connector 802 on the nares portion 820 and to the mouth portion 840 through the connector 30 and the opening 46. In this embodiment, the plug 803 is connected with an opening on the front of the mouth portion 840. Structures for plugging the connection between the nares portion 820 and the mouth portion 840, such as the plug 35 or the valve 55, may be used, and the mouth portion 840 may then serve as a mouth seal.
Optionally, in embodiments including structures that allow pneumatic connection between the nares portion 820 and the mouth portion 840, such as the connector 30 and the opening 46, the patient may connect the connector 30 with the opening 46 and plug the opening in the nares portion 820 using the plug 803. The elbow or other connector 802 may then be connected with an opening in the front of the mouth portion 840 to deliver pressurized air to the mouth portion 840 and through the connector 30 and opening 46 to the nares portion 820. Structures for plugging the connection between the nares portion 820 and the mouth portion 840, such as the plug 35 or the valve 55, may be used, and the nares portion 820 may then serve as a nares seal.
The nares and mouthpiece set 801 may include the components of the nares only set 805 and the mouthpiece 810. The nares and mouth piece assembly 801 may allow the patient to selectively switch between using the nares portion 820 alone, the mouth portion 840 alone, or both the nares portion 820 and the mouth portion 840 together. This allows the patient to periodically change how the device is perceived on the patient's face. For example, if the patient's nares area is irritated (e.g., due to air jets and/or concentrated sealing forces), the patient may switch to using the nares portion 820 and the mouth portion 840, or only the mouth portion 840. The patient may switch periodically, e.g., nightly, weekly, monthly, etc.
Figure 37 illustrates a prior art nasal only CPAP device 901 providing CPAP therapy to the nares of a patient. The CPAP device 901 may include a nares portion 910 that forms a seal with the patient's nares, an elbow connector 912 that connects the nares portion 910 with a tube 915 that supplies pressurized gas to the nares portion 910, wherein the tube extends along the patient's nares between the patient's eyes and over the patient's head, wherein the tube is connected with the pressurized gas supply. The elbow connector may include a vent 914 for venting gases exhaled by the patient, the vent having a removable insert. The nares portion 910 may include a nares sealing portion such as a nasal pillow, nasal prongs, nasal membranes, or nasal chamber. A headband 918 may secure the nares portion 910 to the patient's head.
Fig. 38 shows how a nose-only device 901 of the prior art is converted into a device according to the present inventionA side view of a nares and mouth mask system 940 of an embodiment of the invention. The nares portion 910 and the elbow 912 may be removed and the mask system 940 may be connected with the tube 915, such as by the connector 924. The nose-only device of the prior art may be, for example
Figure BDA0000842447570000601
Provided is a device.
The mask system 940 may include a mouth portion 942 for forming a seal with the mouth of a patient and a nares portion 952 for forming a seal with the nares of the patient. The mouth portion 942 may include a headgear connector 946 for connection with a headgear 954, and the nares portion 952 may include a headgear connector 944 for connection with the headgear 950. The mask system 940 may be a modular mask system or an integrated mask system and is capable of delivering pressurized air to the nostrils and/or mouth of a patient.
The mask system 940 may optionally use a nares portion 910 and add a mouth portion, where the mask system 940 is the mouth portion. In this embodiment, the vent 914 of the elbow 912 is used in connection with the mouth portion 940, with the insert in the vent 914 removed, and the mouth portion 940 adapted to pneumatically connect with the vent. In this embodiment, air may flow out of the vent 914 to the mouth portion 940 and may retain any original headgear, such as the headgear 918.
Figure 39 shows a schematic side view of another variation of a nostril-only device 901. In this embodiment, the nasal pillows 960 are removed from the openings 920 in the nares-only device 901, and the mask system 962 is connected to the nares-only device 901 in place of the nasal pillows 960. The mask system 962 has a pair of connectors 964 adapted to connect with the openings.
The mask system 962 includes a mouth portion 968 and a nares portion 969. The mouth portion 968 forms a seal with the patient's mouth at the mouth seal 974 and receives pressurized air through the connector 964. The mouth portion 968 is connected to the nares portion 969 by a connector 976. The nares portion 969 may include a nares engagement portion 970 adapted to form a seal with the nares of the patient and a support portion 972. The nares portion 969 may alternatively be another type of nares portion, such as a nasal pillow or prongs or nasal cavities.
Mask systems 940 and 962 may be used to convert a nares-only device that delivers respiratory therapy to a patient into a device for delivering nasal and/or mouth respiratory therapy to a patient.
Figure 40 illustrates a prior art nasal only CPAP device 980 providing CPAP therapy to the patient's nares. The CPAP device 980 may include a nares portion 982, the nares portion 982 including cushions 988 that form a seal with the nares of the patient, a connector 990 for connecting with a source of pressurized gas, a headgear connector 985 for connecting with headgear, and a forehead portion 984. The forehead portion 984 includes forehead support pads 986 and dials 994 for adjusting the position of the forehead support pads 986. The cushion 988 can be removed by pulling the cushion 988 in the direction of the arrow.
Fig. 41 illustrates how a prior art nasal only device 980 is converted into a side view of a nares and mouth mask system 993 in accordance with an embodiment of the present invention. The cushion 988 may be removed and the nares and mouth mask system 993 may be connected to the nasal only device in place of the cushion 988.
The nares and mouth mask system 993 may be adapted to connect to the frame of the nasal-only apparatus 980 by forming an interface 987 that is the same shape as the cushion 988 instead of the cushion. The nares and mouth mask system 993 includes a cushion 998 adapted to seal with the patient's face, and may include a nose-engaging portion 994 and a lower lip-engaging portion 995. The headband connector 996 may connect with the headband 997. The nares and mouth mask system 993 may thus be used to convert the nares-only device 980 into a nares and mouth mask system 993. The front portion 999 of the mask system 993 may be formed of a stiffening member to provide additional rigidity.
The nares and mouth mask system 993 may include an AAV (anti-asphyxia valve) that may have an opening 1002 and a flap 1004. When pressure is applied to the mask system 993, such as from an air delivery tube, the flap 1004 is in the closed position. When no pressure is applied, the flap 1004 moves to the open position 1006, allowing the user to breathe through the opening 1002. Although not shown, the embodiment of fig. 39 may also include such an AAV.
The mask system described herein may be used to provide the following: providing respiratory therapy to one of only the patient's nares, only the patient's mouth, or both the patient's nares and mouth, and periodically changing the respiratory therapy provided to the other of only the patient's nares, only the patient's mouth, or both the patient's nares and mouth. For example, respiratory therapy may be initially provided to only the patient's nares and then periodically changed from being applied to only the patient's nares to being applied to the patient's nares and mouth.
The described mask system may also be used in a method of providing a respiratory therapy treatment in which a first mask having a first footprint is applied to a patient for a period of time, the first mask is then removed, and a second mask having a second footprint different from the first footprint is applied to the patient for a second period of time. For example, the first coverage area may be one of a nares-only mask, a nares and mouth mask, and a mouth-only mask, while the second coverage area is another one of a nares-only mask, a nares and mouth mask, and a mouth-only mask.
While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the invention. Also, various embodiments described above can be implemented in combination with other embodiments, e.g., aspects of one embodiment can be combined with aspects of another embodiment to realize yet other embodiments. In addition, each individual feature or element of any given assembly may constitute additional embodiments. Additionally, while the present invention has particular application to patients suffering from OSA, it is to be understood that patients suffering from other illnesses (e.g., congestive heart failure, diabetes, morbid obesity, stroke, bariatric surgery, etc.) can also benefit from the above teachings. Moreover, the above teachings are applicable to patients and similar non-patients in non-medical applications.

Claims (26)

1. A mask system for delivering respiratory therapy to a patient, the mask system comprising:
a nares portion adapted to form a seal with a patient's nares;
a mouth portion comprising a mouth chamber and a mouth seal portion adapted to form a seal with a patient's mouth; and
an input conduit connected with at least one of the nares portion and the mouth portion to deliver pressurized breathable gas to a patient,
wherein the nares portion and the mouth portion are adapted to be selectively attached to and detached from each other,
wherein the mouth portion is adapted to selectively function in both a first configuration in which at least a portion of the pressurized breathable gas is delivered to the patient's mouth and a second configuration in which the mouth portion acts as a mouth seal that prevents any of the pressurized breathable gas from being delivered to the patient's mouth;
wherein the mouth portion is configured such that when the mouth portion is used as a mouth seal in the second configuration, gas in the mouth portion is not in communication with the atmosphere, and
wherein the mouth portion is adapted to selectively function in both a first configuration and a second configuration when the mouth portion is attached to the nose portion, and
wherein the mouth portion is adapted to selectively function in both a first configuration and a second configuration when the mouth portion is detached from the nares portion.
2. The mask system according to claim 1, further comprising a connector in the nares portion connectable with an opening in the mouth chamber to deliver a portion of the pressurized breathable gas between the nares portion and the mouth chamber.
3. The mask system according to any one of claims 1-2, wherein the inlet conduit is connectable with the nares portion to deliver a portion of the pressurized breathable gas to the nares of the patient.
4. The mask system according to any one of claims 1-2, wherein the inlet conduit is connectable with the mouth portion to deliver a portion of the pressurized breathable gas to the patient's mouth.
5. The mask system according to any one of claims 1-2, further comprising a plug adapted to plug an opening in the mouth chamber in the second configuration such that the pressurized breathable gas is not delivered to the mouth chamber.
6. The mask system according to any one of claims 1-2, further comprising a mouth portion sealing arrangement that allows a patient to selectively switch the mouth portion between the first configuration and the second configuration.
7. The mask system according to claim 6, wherein the mouth portion sealing arrangement includes a rotatable knob on the mouth portion.
8. The mask system according to any one of claims 1-2, wherein the nares portion and the mouth portion are removably connected to one another.
9. The mask system according to any one of claims 1-2, further comprising a double elbow connector adapted to connect the input conduit with both the nares portion and the mouth portion for use of the mask system in the first configuration.
10. The mask system according to any one of claims 1-2, further comprising a swivel ring in an opening in the nares portion or the mouth chamber, the swivel ring adapted to connect with the input conduit.
11. The mask system according to any one of claims 1-2, wherein the nares portion and the mouth chamber are formed separately from one another and subsequently connected to one another.
12. The mask system according to any one of claims 1-2, wherein the mouth sealing portion includes a silicone cushion.
13. The mask system according to any one of claims 1-2, wherein at least one of the nares portion and the mouth portion includes a headgear connector adapted to connect with headgear.
14. The mask system according to any one of claims 1-2, wherein both the nares portion and the mouth portion include headgear connectors connected to headgear.
15. The mask system according to claim 13, wherein the headgear includes an upper side strap adapted to be routed between the patient's eyes and ears and a lower side strap routed under the patient's ears.
16. The mask system according to claim 15, wherein the headgear includes a rear strap portion connected with the upper side strap above the patient's ears and adapted to angle downwardly along the sides of the patient's head in use to capture the occiput of the patient's head.
17. The mask system according to claim 13, wherein the headgear includes a crown strap portion adapted to be positioned, in use, on a crown of the patient's head.
18. The mask system according to claim 16, wherein the rear strap portion is connected with the lower side strap below the occiput of the patient's head.
19. The mask system according to any one of claims 1-2, wherein the nares portion includes a nares sealing portion adapted to form a seal with a patient's nares in use.
20. The mask system according to claim 19, wherein the nares sealing portion comprises one of a pillow, a prong, a membrane seal, or a nasal chamber.
21. The mask system according to claim 19, wherein the nares sealing portion is configured to extend or curve outwardly from a support wall defining an air path into the nares sealing portion.
22. The mask system according to claim 19, further comprising a plurality of rigid elements disposed on an underside of the nares sealing portion and a dial connected to the rigid elements, the dial adapted to move the rigid elements up or down when rotated to adjust a clamping force of the nares sealing portion.
23. The mask system according to any one of claims 1-2, wherein the mouth sealing portion includes a foam patient contacting portion.
24. A medical enclosure comprising a kit for converting a CPAP device including a nares only portion to a CPAP device having a nares portion and a mouth portion, the medical enclosure comprising:
a mouth portion comprising a mouth chamber and a mouth seal portion adapted to form a seal with a patient's mouth, the mouth chamber comprising an opening adapted to selectively receive pressurized breathable gas;
a nostril portion interface formed on the mouth portion, the nostril portion interface adapted to receive a nostril portion,
wherein the nares portion is selectively separable from the nares portion interface and is operable as a nares-only device adapted to form a seal with and deliver pressurized breathable gas only to the nares of the patient,
wherein the mouth portion is selectively separable from the nares portion and is operable as a mouth-only device adapted to form a seal with and deliver pressurized breathable gas to only the mouth of the patient,
wherein the nares portion docking interface comprises a docking aperture separate and distinct from an opening of a mouth chamber, and the docking aperture is constructed and arranged to allow selective attachment to the nares portion, and the mouth chamber opening is constructed and arranged to allow selective attachment to an input conduit;
a vent plug adapted to plug a hole in the nares portion;
and headgear adapted to secure at least the mouth portion to the head of the patient.
25. The mask system according to claim 21, wherein the nares and mouth seal portions constitute a seal assembly, and further comprising:
a headgear for holding the seal assembly in place on the patient's head,
the headgear comprising side headgear straps comprising a flexible material configured to stretch longitudinally,
wherein the seal assembly includes a headgear connector having headgear tabs, an
Wherein each of the side headgear straps includes an aperture configured to connect to a respective one of the headgear flaps.
26. A retrofit kit adapted to convert a nares-only device for delivering respiratory therapy to a patient into a nares and mouth-type device for delivering respiratory therapy to a patient, the retrofit kit comprising:
a mouth portion comprising a mouth chamber and a mouth seal portion adapted to form a seal with a patient's mouth, the mouth chamber including an opening adapted to selectively receive pressurized breathable gas, the mouth portion adapted to enable the nares-only device to function as a nares and a mouth-only device,
wherein the mouth portion comprises an opening adapted to pneumatically connect to a nares-only device, the opening adapted to receive a connector on the nares-only device;
a plug adapted to connect with the opening in the mouth chamber or an opening in the nostril-only device;
a headgear adapted to secure at least the mouth portion to a patient's head;
an elbow adapted to connect to an opening in the mouth chamber or an opening in the nares-only device to deliver pressurized breathable gas; and
a double elbow adapted to connect to both an opening in the mouth chamber and an opening in the nares-only device to deliver pressurized breathable gas.
CN201510757297.0A 2010-09-30 2011-09-30 Mask system Active CN105396207B (en)

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
US38835710P 2010-09-30 2010-09-30
US61/388,357 2010-09-30
US201161443623P 2011-02-16 2011-02-16
US61/443,623 2011-02-16
US201161457981P 2011-07-27 2011-07-27
US61/457,981 2011-07-27
US201161528524P 2011-08-29 2011-08-29
US61/528,524 2011-08-29
CN201180047592.7A CN103153378B (en) 2010-09-30 2011-09-30 Mask system
PCT/AU2011/001259 WO2012040792A1 (en) 2010-09-30 2011-09-30 Mask system

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN201180047592.7A Division CN103153378B (en) 2010-09-30 2011-09-30 Mask system

Publications (2)

Publication Number Publication Date
CN105396207A CN105396207A (en) 2016-03-16
CN105396207B true CN105396207B (en) 2020-01-10

Family

ID=76599571

Family Applications (2)

Application Number Title Priority Date Filing Date
CN201180047592.7A Active CN103153378B (en) 2010-09-30 2011-09-30 Mask system
CN201510757297.0A Active CN105396207B (en) 2010-09-30 2011-09-30 Mask system

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CN201180047592.7A Active CN103153378B (en) 2010-09-30 2011-09-30 Mask system

Country Status (7)

Country Link
US (11) US9737678B2 (en)
EP (3) EP3231470B1 (en)
JP (2) JP6046626B2 (en)
CN (2) CN103153378B (en)
AU (2) AU2011308095B2 (en)
NZ (5) NZ713055A (en)
WO (1) WO2012040792A1 (en)

Families Citing this family (140)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USD485905S1 (en) * 2002-08-09 2004-01-27 Resmed Limited Nasal mask
USD623288S1 (en) * 2006-04-28 2010-09-07 Resmed Limited Patient interface
USD637279S1 (en) * 2008-01-11 2011-05-03 Resmed Limited Strap and yoke for mask
US9981104B1 (en) 2008-02-19 2018-05-29 Circadiance, Llc Full face cloth respiratory mask
NZ725939A (en) 2009-06-02 2018-06-29 Resmed Ltd Unobtrusive nasal mask
USD691257S1 (en) * 2010-08-23 2013-10-08 Fisher & Paykel Healthcare Limited Seal for a patient interface
AU2011308094B2 (en) 2010-09-30 2014-05-01 Resmed Limited Patient interface systems
NZ713055A (en) 2010-09-30 2017-04-28 Resmed Ltd Mask system
CN103269742A (en) * 2010-12-21 2013-08-28 皇家飞利浦电子股份有限公司 Support element for use with patient interface device
CA3219881A1 (en) 2011-04-15 2012-10-18 Fisher & Paykel Healthcare Limited Interface comprising a rolling nasal bridge portion
US10603456B2 (en) 2011-04-15 2020-03-31 Fisher & Paykel Healthcare Limited Interface comprising a nasal sealing portion
USD692554S1 (en) 2011-09-08 2013-10-29 Fisher & Paykel Healthcare Limited Patient interface assembly
US9579478B2 (en) 2011-11-03 2017-02-28 Koninklijke Philips N.V. Modular patient interface device with chamber and nasal pillows assembly
US10905842B2 (en) 2011-11-21 2021-02-02 Snap Cpap, Llc Respiratory assembly
US11207484B2 (en) 2011-11-21 2021-12-28 Snap Cpap, Llc Respiratory assembly
NZ627433A (en) 2012-03-30 2016-03-31 Resmed Ltd Patient interface
JP6195914B2 (en) * 2012-06-07 2017-09-13 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． Full face mask for children
JP5895103B2 (en) * 2012-07-16 2016-03-30 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． Cradle cushion with lateral stabilizer
CN106912194B (en) 2012-07-27 2020-03-20 瑞思迈私人有限公司 Patient interface and method for manufacturing the same
WO2014021722A1 (en) 2012-08-03 2014-02-06 Fisher & Paykel Healthcare Limited Deformable insert for low pressure patient interface
US9950130B2 (en) 2012-09-04 2018-04-24 Fisher & Paykel Healthcare Limited Valsalva mask
US20150246199A1 (en) * 2012-09-19 2015-09-03 Koninklijke Philips N.V. Articulating full face mask
WO2014062070A1 (en) 2012-10-17 2014-04-24 Fisher & Paykel Healthcare Limited Interface comprising a nasal sealing portion and a rolling hinge
CN104870041B (en) * 2012-12-13 2017-05-31 皇家飞利浦有限公司 Patient interface pad with overall bandage
JP6422880B2 (en) * 2012-12-18 2018-11-14 コーニンクレッカ フィリップス エヌ ヴェＫｏｎｉｎｋｌｉｊｋｅ Ｐｈｉｌｉｐｓ Ｎ．Ｖ． Motion stabilizer system for respiratory interface devices
AU2014207247B2 (en) * 2013-01-16 2017-03-02 ResMed Pty Ltd Patient interface and method for making same
CN105120935B (en) 2013-01-18 2017-10-27 瑞思迈有限公司 Patient interface and its manufacture method
US10413692B2 (en) 2013-02-04 2019-09-17 ResMed Pty Ltd Cushion assembly
US10004867B2 (en) * 2013-02-04 2018-06-26 Resmed Limited Respiratory apparatus
USD809131S1 (en) 2014-08-04 2018-01-30 Resmed Limited Respiratory mask assembly
NZ745260A (en) 2013-02-04 2020-03-27 ResMed Pty Ltd Respiratory apparatus
US10987477B2 (en) 2013-02-04 2021-04-27 ResMed Pty Ltd Respiratory apparatus
WO2014141029A1 (en) * 2013-03-13 2014-09-18 Koninklijke Philips N.V. Subnasal sealing cushion and patient interface device employing same cross-reference to related applications
USD757252S1 (en) * 2013-04-12 2016-05-24 Resmed Limited Patient interface
NZ714593A (en) * 2013-04-12 2017-08-25 Resmed Ltd Neck strap, crown strap assembly and headgear for a breathing mask
CN105142705B (en) * 2013-04-23 2019-04-16 皇家飞利浦有限公司 Patient interface device
JP6336575B2 (en) * 2013-04-26 2018-06-06 フィッシャー アンド ペイケル ヘルスケア リミテッド Respirator headgear
BR302013005431S1 (en) * 2013-05-07 2014-09-09 Koninkl Philips Nv CONFIGURATION APPLIED TO ELBOW PATIENT INTERFACE SET CONNECTOR
TWI765097B (en) * 2013-05-07 2022-05-21 紐西蘭商費雪＆佩凱爾關心健康有限公司 Patient interface and headgear for a respiratory apparatus
TWI803000B (en) * 2013-05-14 2023-05-21 澳大利亞商瑞思邁私人股份有限公司 Oro-nasal patient interface
NZ631020A (en) 2013-05-14 2017-06-30 Resmed Ltd Oro-nasal patient interface
MX2015017679A (en) * 2013-06-28 2016-08-03 Revolutionary Medical Devices Inc Positioning device and method for use with a patient under anesthesia.
JP6581980B2 (en) 2013-07-17 2019-09-25 フィッシャー アンド ペイケル ヘルスケア リミテッド Patient interface and aspects thereof
EP3865168A1 (en) 2013-08-05 2021-08-18 Fisher & Paykel Healthcare Limited Interface
US20160263339A1 (en) * 2013-10-29 2016-09-15 Koninklijke Philips N.V. Convertible patient interface device
EP3062858B1 (en) * 2013-11-01 2018-10-10 Koninklijke Philips N.V. Sealing cushion for a patient interface
NZ720335A (en) 2013-11-15 2021-07-30 ResMed Pty Ltd Patient interface and method for making same
USD770036S1 (en) 2013-11-27 2016-10-25 Fisher & Paykel Healthcare Limited Breathing interface assembly
WO2015079396A1 (en) 2013-11-27 2015-06-04 Fisher & Paykel Healthcare Limited Headgear assembly for breathing interface
USD764049S1 (en) * 2013-12-12 2016-08-16 Redmed Limited Patient interface
USD740935S1 (en) 2013-12-12 2015-10-13 Resmed Limited Frame for patient interface
RU2695885C1 (en) * 2013-12-20 2019-07-29 Конинклейке Филипс Н.В. Individually adjustable face sealing element for respiratory device and individual adjustment method
USD771238S1 (en) 2014-01-16 2016-11-08 Resmed Limited Combined plenum, seal and clip module for patient interface
SG10201807070YA (en) * 2014-02-26 2018-09-27 Fisher & Paykel Healthcare Ltd Respiratory mask with nasogastric tube path
EP3122410B1 (en) * 2014-03-26 2021-07-21 Mask Solutions LLC Cushion for patient interface device, breathing mask with cushion, and method and apparatus for same
WO2015170207A1 (en) * 2014-05-06 2015-11-12 Koninklijke Philips N.V. Determining patient interface device optimal hardness
USD771239S1 (en) 2014-05-08 2016-11-08 Fisher & Paykel Healthcare Limited Crown strap of a headgear assembly for a breathing interface
US10232137B2 (en) 2014-05-22 2019-03-19 Resmed Limited Patient interface
US20170173290A1 (en) * 2014-06-04 2017-06-22 Revolutionary Medical Devices ,Inc. Combined nasal and mouth ventilation mask
SG11201608616VA (en) 2014-06-17 2017-01-27 Fisher & Paykel Healthcare Ltd Patient interfaces
NZ748310A (en) * 2014-06-19 2020-05-29 ResMed Pty Ltd Patient interface for respiratory therapy
SG10201913708XA (en) * 2014-07-18 2020-03-30 Fisher & Paykel Healthcare Ltd Headgear clip arrangement
EP3183023B1 (en) 2014-08-20 2021-04-14 Revolutionary Medical Devices, Inc. Ventilation mask
AU2015307325A1 (en) 2014-08-25 2017-04-06 Fisher & Paykel Healthcare Limited Respiratory mask and related portions, components or sub-assemblies
USD797921S1 (en) 2014-11-07 2017-09-19 Fisher & Paykel Healthcare Limited Breathing apparatus
US11351323B2 (en) * 2014-11-14 2022-06-07 Fisher & Paykel Healthcare Limited Patient interface for PAP therapy with rigid headgear connection elements
NZ770085A (en) * 2014-11-26 2023-06-30 ResMed Pty Ltd Textile patient interface
WO2016094429A1 (en) * 2014-12-08 2016-06-16 Human Design Medical, Llc A hybrid positive airway interface system for use with ventilation and positive air pressure systems
US20160158474A1 (en) * 2014-12-08 2016-06-09 Human Design Medical, Llc Facial mask with internal support structure for use with ventilation and positive air pressure systems
USD825740S1 (en) 2014-12-12 2018-08-14 Revolutionary Medical Devices Surgical mask
US9897812B2 (en) * 2015-01-22 2018-02-20 Oculus Vr, Llc. Strap system for virtual reality head-mounted display
US10898668B2 (en) * 2015-03-04 2021-01-26 ResMed Pty Ltd Plastic to textile coupling for a patient interface and methods of manufacturing same
EP3259002B1 (en) * 2015-03-31 2022-03-09 Fisher&Paykel Healthcare Limited A user interface for supplying gases to an airway
ES2910409T3 (en) 2015-03-31 2022-05-12 Fisher & Paykel Healthcare Ltd System for administering gases to an airway
USD799699S1 (en) * 2015-10-09 2017-10-10 Koninklijke Philips N.V. Mask frame for CPAP therapy
EP3915622B1 (en) 2015-06-11 2023-09-13 SunMed Group Holdings, LLC Ventilation mask
US10182284B2 (en) * 2015-06-11 2019-01-15 Facebook Technologies, Llc Connector assembly for detachable audio system
US11077273B2 (en) * 2015-07-20 2021-08-03 ResMed Pty Ltd Patient interface with volume reducing member
WO2017037638A1 (en) 2015-09-04 2017-03-09 Fisher & Paykel Healthcare Limited Patient interfaces
CN108136149B (en) 2015-09-23 2021-05-07 瑞思迈私人有限公司 Patient interface including seal-forming structures having different thicknesses
US10799661B2 (en) 2015-09-23 2020-10-13 ResMed Pty Ltd Patient interface with a seal-forming structure having varying thickness
CN108025156B (en) * 2015-10-06 2021-01-15 斯奈普斯帕有限责任公司 Breathing assembly
US11511066B2 (en) 2015-10-06 2022-11-29 Snap Cpap, Llc Respiratory assembly
CN105413035A (en) * 2015-12-24 2016-03-23 北京怡和嘉业医疗科技有限公司 Liner for breathing mask and breathing mask
EP3402560B1 (en) 2016-01-14 2022-03-23 ResMed Pty Ltd Oro-nasal patient interface
EP3981457A1 (en) * 2016-01-21 2022-04-13 ResMed Pty Ltd Adjustable headgear tubing for a patient interface
CN109414557B (en) 2016-04-28 2022-08-30 瑞思迈私人有限公司 Patient interface
USD882066S1 (en) 2016-05-13 2020-04-21 Fisher & Paykel Healthcare Limited Frame for a breathing mask
CN109310841B (en) * 2016-06-16 2022-03-11 皇家飞利浦有限公司 Magnetically assisted seal arrangement for patient interface device
EP3995168A1 (en) 2016-08-11 2022-05-11 Fisher & Paykel Healthcare Limited A collapsible conduit, patient interface and headgear connector
EP3988018A1 (en) 2016-09-14 2022-04-27 Revolutionary Medical Devices, Inc. Ventilation mask
US9629975B1 (en) 2016-09-14 2017-04-25 Revolutionary Medical Devices, Inc. Ventilation mask
US20210283359A1 (en) * 2016-10-03 2021-09-16 University Of Tennessee Research Foundation Continuous positive airway pressure (cpap) devices and systems
WO2018064712A2 (en) 2016-10-04 2018-04-12 Resmed Asia Operations Pty Ltd Patient interface with movable frame
AU2017339844B2 (en) 2016-10-05 2023-01-05 Fisher & Paykel Healthcare Limited Patient interfaces
USD848606S1 (en) 2016-11-07 2019-05-14 Revolutionary Medical Devices, Inc. Surgical mask
USD829322S1 (en) * 2016-12-05 2018-09-25 Koninklijke Philips N.V. Mask
KR101898799B1 (en) * 2017-01-19 2018-09-13 쓰리엠 이노베이티브 프로퍼티즈 캄파니 Head cradle including a head band member having excellent flexibility
USD823454S1 (en) 2017-02-23 2018-07-17 Fisher & Paykel Healthcare Limited Cushion assembly for breathing mask assembly
USD824020S1 (en) 2017-02-23 2018-07-24 Fisher & Paykel Healthcare Limited Cushion assembly for breathing mask assembly
USD823455S1 (en) 2017-02-23 2018-07-17 Fisher & Paykel Healthcare Limited Cushion assembly for breathing mask assembly
WO2018177794A1 (en) 2017-03-28 2018-10-04 Koninklijke Philips N.V. Valve arrangement for full face mask
AU2018273458B2 (en) * 2017-05-22 2024-02-15 Fisher & Paykel Healthcare Limited A respiratory user interface
USD898188S1 (en) 2017-11-17 2020-10-06 Revolutionary Medical Devices, Inc. Surgical mask
WO2019156921A1 (en) * 2018-02-08 2019-08-15 Snap Cpap, Llc Self-sanitizing respiratory assembly and methods of making and using the same
USD884153S1 (en) 2018-04-04 2020-05-12 Fisher & Paykel Healthcare Limited Frame for a mask assembly
USD942614S1 (en) 2018-07-10 2022-02-01 ResMed Pty Ltd Combined cushion and frame module for patient interface
USD924388S1 (en) 2018-07-10 2021-07-06 ResMed Pty Ltd Patient interface
CN113195026A (en) 2018-08-20 2021-07-30 瑞思迈私人有限公司 Headgear for a patient interface
USD942615S1 (en) 2018-09-12 2022-02-01 ResMed Pty Ltd Patient interface
US11554236B2 (en) * 2018-12-24 2023-01-17 Koninklijke Philips N.V. Patient interface device having magnetic coupling features
WO2020140100A1 (en) * 2018-12-27 2020-07-02 Respitore, LLC Oro-nasal ventilation face mask
AU2020222309B2 (en) 2019-02-13 2021-10-28 ResMed Pty Ltd Textile seal with air-assisted biasing portion
US20220143432A1 (en) * 2019-02-14 2022-05-12 Jaime C. SALLES Protective respiratory mask
TWM585155U (en) * 2019-02-27 2019-10-21 台灣基督長老教會馬偕醫療財團法人馬偕紀念醫院 Breathing mask
WO2020191463A1 (en) * 2019-03-28 2020-10-01 ResMed Pty Ltd Patient interface
US20200376221A1 (en) * 2019-05-31 2020-12-03 ResMed Pty Ltd Patient interface
US20220296837A1 (en) * 2019-07-22 2022-09-22 ResMed Pty Ltd Patient interface
JP2022542994A (en) * 2019-07-31 2022-10-07 レスメド・プロプライエタリー・リミテッド Patient interface having seal-forming structure with variable geometry
EP4003477A4 (en) * 2019-07-31 2023-08-02 ResMed Pty Ltd Modular headgear
WO2021040814A1 (en) * 2019-08-23 2021-03-04 NOTA Laboratories, LLC Nitric oxide generating systems for nasal inhalation
WO2021046605A1 (en) * 2019-09-10 2021-03-18 ResMed Pty Ltd Patient interface and positioning and stabilising structure for the patient interface
CN114728145A (en) * 2019-09-10 2022-07-08 瑞思迈私人有限公司 Treatment system for respiratory-related conditions and patient interface and headgear therefor
WO2021046599A1 (en) * 2019-09-10 2021-03-18 ResMed Pty Ltd Oro-nasal patient interface
US20220395660A1 (en) * 2019-10-30 2022-12-15 ResMed Pty Ltd Modular patient interface including a joint coupling mouth and nasal cushions
WO2021137765A1 (en) * 2019-12-31 2021-07-08 ResMed Asia Pte Ltd A patient interface formed from a textile construction and including a stiffened portion to provide for customization
CN113521472A (en) * 2020-04-14 2021-10-22 北京荣瑞世纪科技有限公司 Nose respirator
US11426551B1 (en) 2020-06-23 2022-08-30 Lisa M. Butler, Esquire Nasal ventilation mask
EP4181997A1 (en) * 2020-07-20 2023-05-24 ResMed Pty Ltd A patient interface and a positioning and stabilising structure
EP4188497A1 (en) 2020-07-30 2023-06-07 ResMed Pty Ltd Seal-forming structure of patient interface with multiple sealing materials
USD958324S1 (en) 2020-08-19 2022-07-19 Koller Enterprises, Inc. Clear face mask
CN112169108A (en) * 2020-10-20 2021-01-05 赣南医学院第一附属医院 Severe patient breathes recovery auxiliary device
WO2022099377A1 (en) * 2020-11-13 2022-05-19 ResMed Pty Ltd Patient interface system
WO2022158987A1 (en) * 2021-01-19 2022-07-28 Fisher & Paykel Healthcare Limited Patient interface
CN113029628B (en) * 2021-04-01 2022-08-19 青岛精安医疗科技有限责任公司 Breathing simulation device and method
CN113181496A (en) * 2021-05-05 2021-07-30 台州恩泽医疗中心(集团) Multifunctional noninvasive humidifying breathing mask
CN114010902B (en) * 2021-09-30 2024-03-19 天津怡和嘉业医疗科技有限公司 Oral nasal cushion and patient interface device
US11471634B1 (en) * 2021-12-14 2022-10-18 ResMed Pty Ltd Oro-pillow cushion assembly
CN116747392B (en) * 2023-07-06 2024-04-09 中国人民解放军总医院第六医学中心 Respiratory tract pressure regulation type breathing machine
USD1014735S1 (en) * 2023-08-04 2024-02-13 Dcstar Inc. Mask frame

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6123071A (en) * 1993-06-18 2000-09-26 Resmed Limited Facial masks for assisted respiration or CPAP
US6263874B1 (en) * 1997-11-18 2001-07-24 Ledez Kenneth Michael Combined anesthetic and scavenger mask
CN101237902A (en) * 2005-06-06 2008-08-06 雷斯梅德有限公司 Mask system

Family Cites Families (182)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US122905A (en) 1872-01-23 Improvement in hand-screws
GB190901085A (en) * 1909-01-15 1909-12-23 Dental Mfg Co Ltd Improvements in and relating to Anæsthetic Inhaling Apparatus.
US1192186A (en) 1910-09-20 1916-07-25 Samuel Ward Greene Respirator.
GB191501085A (en) 1915-01-22 1915-07-01 Stothert & Pitt Ltd Improvements in Controlling and Indicating Electric Motors from a Distance and in the application thereof to Weighing Machines.
US1229050A (en) 1917-03-29 1917-06-05 Robert Donald Respirator.
US1362766A (en) 1919-11-07 1920-12-21 Mcgargill James Martin Gas-mask
US1445010A (en) 1920-11-15 1923-02-13 William S Feinberg Breathing apparatus for swimmers
US1710160A (en) 1925-02-04 1929-04-23 Gibbs Wahlert Mask Co Inc Respirator
US2126755A (en) 1934-08-04 1938-08-16 Dreyfus Camille Method of making a composite fabric
US2130555A (en) 1936-04-06 1938-09-20 Malcom Robert Respirator filter
US2228218A (en) 1936-11-25 1941-01-07 Hygeia Filtering Corp Respirator
US2578621A (en) 1945-12-29 1951-12-11 Mine Safety Appliances Co Respirator mask
US2706983A (en) 1951-09-15 1955-04-26 Willson Products Inc Flexible construction in respirator mask facepiece
US3424633A (en) 1964-07-10 1969-01-28 Vanderbilt Co R T Method of making strap material
US3330273A (en) 1964-10-15 1967-07-11 Puritan Compressed Gas Corp Oro-nasal face mask with improved sealing cuff
US4126131A (en) * 1977-03-18 1978-11-21 Sierra Engineering Co. Facemask and goggle combination for excluding smoke or noxious gases from the goggles
US4248218A (en) 1978-09-22 1981-02-03 Fischer Charles M Gas administration scavenging mask
US4263908A (en) 1979-07-25 1981-04-28 Mizerak Vladimir S Nasal cannula mask
US4537192A (en) 1980-07-11 1985-08-27 Foster Billy R Unitary endotracheal tube holder
DE3276924D1 (en) 1981-04-24 1987-09-17 Somed Pty Ltd Device for treating snoring sickness
US4676236A (en) 1983-09-09 1987-06-30 Gentex Corporation Helmet airflow system
US4676241A (en) 1984-01-16 1987-06-30 W.L.G. Technology Ventilation tube swivel
US4782832A (en) 1987-07-30 1988-11-08 Puritan-Bennett Corporation Nasal puff with adjustable sealing means
US5062421A (en) 1987-11-16 1991-11-05 Minnesota Mining And Manufacturing Company Respiratory mask having a soft, compliant facepiece and a thin, rigid insert and method of making
US4919128A (en) 1988-08-26 1990-04-24 University Technologies International Inc. Nasal adaptor device and seal
US5042478A (en) 1988-08-26 1991-08-27 University Technologies International, Inc. Method of ventilation using nares seal
AU108058S (en) 1988-09-30 1990-06-28 Resmed Ltd A nasal manifold
US5005571A (en) * 1988-11-25 1991-04-09 Dietz Henry G Mouth nose mask for use with an inhalation therapy and/or breathing monitoring apparatus
US4989596A (en) 1989-02-14 1991-02-05 Macris Allen G Face chamber
US5265595A (en) * 1989-06-19 1993-11-30 Hans Rudolph, Inc. Mask for breath analysis
DE4004157C1 (en) 1990-02-10 1991-04-11 Draegerwerk Ag, 2400 Luebeck, De Respiratory nose-mouth half mask - has body with peripheral seal bead to define separate compartments
US5243971A (en) 1990-05-21 1993-09-14 The University Of Sydney Nasal mask for CPAP having ballooning/moulding seal with wearer's nose and facial contours
US5018519B1 (en) * 1990-08-03 2000-11-28 Porter Instr Company Inc Mask for administering an anesthetic gas to a patient
DE69232480T2 (en) * 1991-12-20 2002-11-21 Resmed Ltd Ventilator for generating continuous positive airway pressure (CPAP)
US5375593A (en) 1994-02-10 1994-12-27 Press; John R. Oxygenating pacifier
US5513634A (en) 1994-05-06 1996-05-07 Chek-Med Systems, Inc. Combination integral bite block airway and nasal cannula
US5724965A (en) * 1995-06-06 1998-03-10 Respironics Inc. Nasal mask
US5662101A (en) 1995-12-07 1997-09-02 Respironics, Inc. Respiratory facial mask
US5657752A (en) 1996-03-28 1997-08-19 Airways Associates Nasal positive airway pressure mask and method
US6192886B1 (en) 1996-10-17 2001-02-27 Hans Rudolph, Inc. Nasal mask
US5921239A (en) 1997-01-07 1999-07-13 Sunrise Medical Hhg Inc. Face mask for patient breathing
US5746201A (en) 1997-01-23 1998-05-05 Nellcor Puritan-Bennett CPAP nose mask
AUPO504597A0 (en) 1997-02-10 1997-03-06 Resmed Limited A mask and a vent assembly therefor
US6119694A (en) * 1997-07-24 2000-09-19 Respironics Georgia, Inc. Nasal mask and headgear
US6062221A (en) 1997-10-03 2000-05-16 3M Innovative Properties Company Drop-down face mask assembly
US6016804A (en) 1997-10-24 2000-01-25 Scott Technologies, Inc. Respiratory mask and method of making thereof
US6796308B2 (en) 1998-12-09 2004-09-28 Resmed Limited Mask cushion and frame assembly
AUPQ102999A0 (en) 1999-06-18 1999-07-08 Resmed Limited A connector for a respiratory mask and a respiratory mask
AUPP812199A0 (en) 1999-01-12 1999-02-04 Resmed Limited Headgear
US6338342B1 (en) 1999-02-22 2002-01-15 Cabot Safety Intermediate Corporation Respirator headpiece and release mechanism
US6478026B1 (en) 1999-03-13 2002-11-12 Thomas J. Wood Nasal ventilation interface
US6412488B1 (en) 1999-05-12 2002-07-02 Respironics, Inc. Low contact nasal mask and system using same
US7219669B1 (en) 1999-06-08 2007-05-22 Sleepnet Corporation Nose mask
US6631718B1 (en) 1999-06-08 2003-10-14 Sleepnet Corporation Air mask with seal
US6644315B2 (en) 1999-06-18 2003-11-11 Saeed Ziaee Nasal mask
US6467483B1 (en) 1999-07-28 2002-10-22 Respironics, Inc. Respiratory mask
US6435181B1 (en) 1999-08-30 2002-08-20 Sunrise Medical Hhg Inc. Respiratory mask with adjustable exhaust vent
DE19944242A1 (en) * 1999-09-15 2001-03-22 Dentallabor Negurescu Gmbh Medical breathing mask with nose and mouth pieces joins these via orifice and flexible connector tube to breathing apparatus.
US6621790B1 (en) * 1999-12-30 2003-09-16 3Com Corporation Link aggregation repeater process
EP1900388B1 (en) 2000-02-25 2013-06-05 ResMed R&D Germany GmbH Seal device for a respiratory mask
US6581594B1 (en) 2000-05-15 2003-06-24 Resmed Limited Respiratory mask having gas washout vent and gas washout vent for respiratory mask
US6986352B2 (en) 2000-06-22 2006-01-17 Resmed Limited Mask with gusset
DE10035946C2 (en) 2000-07-21 2002-06-27 Map Gmbh Bracket for a breathing mask
US6530373B1 (en) 2000-08-04 2003-03-11 Mallinckrodt Inc. Respirator mask
US20020020416A1 (en) 2000-08-11 2002-02-21 David Namey Two-shot injection molded nasal/oral mask
US6584975B1 (en) 2000-08-28 2003-07-01 Eldridge Taylor Respirator mask for filtering breathed air
US6418928B1 (en) 2000-09-25 2002-07-16 Mallinckrodt Inc. Multi-seal respirator mask
DE20017940U1 (en) * 2000-10-19 2000-12-28 Map Gmbh Breathing mask for supplying a breathing gas to a mask user and a derivation device for deriving breathing gas
US6431172B1 (en) 2000-10-20 2002-08-13 Mallinckrodt Inc. Nasal cannula with inflatable plenum chamber
EP1349602B1 (en) 2000-12-12 2013-10-30 ResMed Limited Headgear
US7007696B2 (en) 2001-05-18 2006-03-07 Tiara Medical Systems, Inc. Mask cushion and method of using same
US6851425B2 (en) 2001-05-25 2005-02-08 Respironics, Inc. Exhaust port assembly for a pressure support system
US6860270B2 (en) 2001-08-02 2005-03-01 Joseph A. Sniadach Double barrel ventilation mask for a patient
US6817362B2 (en) 2001-08-10 2004-11-16 North Safety Products Inc. Respirator
US7753050B2 (en) * 2001-09-07 2010-07-13 Resmed Limited Headgear connection assembly for a respiratory mask assembly
JP4467875B2 (en) 2001-09-07 2010-05-26 レスメド・リミテッド Mask assembly
DE50214539D1 (en) 2001-10-22 2010-08-26 Map Medizin Technologie Gmbh Medical mask
US7155133B2 (en) 2002-02-12 2006-12-26 Finisar Corporation Avalanche photodiode controller circuit for fiber optics transceiver
GB0204161D0 (en) 2002-02-22 2002-04-10 Smiths Group Plc Mask apparatus
GB0205447D0 (en) 2002-03-08 2002-04-24 Smiths Group Plc Mask apparatus
AUPS192602A0 (en) 2002-04-23 2002-05-30 Resmed Limited Nasal mask
US7743767B2 (en) 2002-04-23 2010-06-29 Resmed Limited Ergonomic and adjustable respiratory mask assembly with frame
US8042542B2 (en) 2002-04-23 2011-10-25 Resmed Limited Respiratory mask assembly with magnetic coupling to headgear assembly
US6786485B2 (en) 2002-08-30 2004-09-07 Shlomo Ruvane Frieman Dice game apparatus and methods for using same
EP2913079B1 (en) 2002-09-06 2017-10-25 ResMed Limited Cushion for respiratory mask assembly
WO2004022147A1 (en) 2002-09-06 2004-03-18 Resmed Limited Elbow for mask assembly
US6857428B2 (en) 2002-10-24 2005-02-22 W. Keith Thornton Custom fitted mask and method of forming same
NZ583274A (en) 2002-11-06 2011-06-30 Resmed Ltd Mask cushion including membrane, undercushion and flexible element
CN101837156B (en) 2002-11-08 2012-07-04 雷斯梅德有限公司 Headgear assembly for a respiratory mask assembly
US9155855B2 (en) 2002-12-06 2015-10-13 Fisher & Paykel Healthcare Limited Mouthpiece
WO2004073777A1 (en) 2003-02-21 2004-09-02 Resmed Limited Nasal mask assembly
NZ626589A (en) 2003-02-21 2016-01-29 Resmed Ltd Nasal assembly
US20040211428A1 (en) * 2003-02-28 2004-10-28 Sunrise Medical Hhg Inc. Nasal mask cushion
US7621274B2 (en) 2003-03-22 2009-11-24 Invacare Corporation Nasal mask
EP3308818A1 (en) * 2003-05-02 2018-04-18 ResMed Ltd. Mask system
US20050011524A1 (en) 2003-07-17 2005-01-20 Marguerite Thomlinson Nasal interface apparatus
US7353826B2 (en) 2003-08-08 2008-04-08 Cardinal Health 205, Inc. Sealing nasal cannula
US7357136B2 (en) 2003-08-18 2008-04-15 Ric Investments, Llc Patient interface assembly and system using same
AU2004268479B2 (en) 2003-09-03 2008-12-11 Fisher & Paykel Healthcare Limited A mask
AU2004277844C1 (en) 2003-10-08 2011-01-20 Fisher & Paykel Healthcare Limited Breathing assistance apparatus
EP2392374B1 (en) 2003-11-11 2016-06-08 ResMed R&D Germany GmbH Headband device for a breathing mask
EP1691871A4 (en) 2003-11-25 2010-09-29 Resmed Ltd Vent system for cpap patient interface used in treatment of sleep disordered breathing
WO2005063328A1 (en) * 2003-12-31 2005-07-14 Resmed Ltd Compact oronasal patient interface
US7178525B2 (en) 2004-02-06 2007-02-20 Ric Investments, Llc Patient interface assembly supported under the mandible
US8783257B2 (en) 2004-02-23 2014-07-22 Fisher & Paykel Healthcare Limited Breathing assistance apparatus
US7856982B2 (en) 2004-03-11 2010-12-28 Ric Investments, Llc Patient interface device
US9072852B2 (en) 2004-04-02 2015-07-07 Fisher & Paykel Healthcare Limited Breathing assistance apparatus
EP1753495B1 (en) 2004-06-03 2010-09-08 Compumedics Limited Adaptable breathing mask
WO2005118040A1 (en) 2004-06-03 2005-12-15 Resmed Limited Cushion for a patient interface
NZ587820A (en) 2004-06-16 2012-03-30 Resmed Ltd Cushion with a gusset for a respiratory mask assembly
DE202005021927U1 (en) 2004-06-25 2011-06-09 ResMed Ltd., New South Wales Forehead support for a patient interface
GB0414372D0 (en) 2004-06-26 2004-07-28 Clarehill Plastics Ltd Rotational moulding product and process
US7243650B2 (en) 2004-07-12 2007-07-17 Thornton W Keith Custom fitted mask configured for coupling to an external gas supply system and method of forming same
CN2721141Y (en) 2004-08-27 2005-08-31 鸿图医疗器材制造厂有限公司 Face mask for breathing
US7353827B2 (en) 2004-09-01 2008-04-08 Vitol Signs, Inc. Mask, mask shell and seal with improved mounting, mask seal, method of mask manufacture and mask with reduced exhalation noise
US7624735B2 (en) 2004-09-21 2009-12-01 Respironics Respiratory Drug Delivery (Uk) Ltd Cheek-mounted patient interface
US8261745B2 (en) * 2004-12-10 2012-09-11 Respcare, Inc. Ventilation interface
US8042539B2 (en) 2004-12-10 2011-10-25 Respcare, Inc. Hybrid ventilation mask with nasal interface and method for configuring such a mask
WO2006072128A1 (en) 2005-01-03 2006-07-13 Resmed Limited Headgear assembly for patient interface
US8297283B2 (en) 2005-01-12 2012-10-30 Resmed Limited Respiratory masks with gusseted cushions
EP2705870B1 (en) 2005-01-12 2019-11-13 ResMed Pty Ltd Cushion for patient interface
US7178528B2 (en) 2005-03-01 2007-02-20 Lau Greg Y Headgear for noninvasive ventilation interface
US20060207597A1 (en) 2005-03-15 2006-09-21 Wright Clifford A Adjustable bite block for respirator
US7287528B2 (en) * 2005-04-13 2007-10-30 Ric Investments, Llc Cushion inside a cushion patient interface
US7513255B2 (en) 2005-06-03 2009-04-07 Ric Investments, Llc Patient interface device with universal headgear mounting member
US8286635B2 (en) 2005-07-08 2012-10-16 Resmed Limited Headgear for mask assembly
US7909035B2 (en) * 2005-07-11 2011-03-22 Airway Technologies, Llc Multi-chamber mask and method of forming the same
WO2007014088A2 (en) 2005-07-25 2007-02-01 Cook Incorporated Intraluminal prosthesis and stent
US8245711B2 (en) 2005-08-15 2012-08-21 Ric Investments, Llc Patient interface with adjustable cushion
WO2007025329A1 (en) 2005-08-29 2007-03-08 Resmed Ltd Mouth seal assembly for nasal mask system
WO2007041751A1 (en) 2005-10-14 2007-04-19 Resmed Limited Cushion to frame assembly mechanism
US9295805B2 (en) 2005-10-17 2016-03-29 Resmed Limited Anti-asphyxia valve assembly for respirator mask
US20090126739A1 (en) * 2005-10-25 2009-05-21 Resmed Limited Interchangeable Mask Assembly
US7762258B2 (en) 2005-12-02 2010-07-27 Carefusion 2200, Inc. Infant nasal interface mask
US7448386B2 (en) 2005-12-07 2008-11-11 Ric Investments, Llc Full face respiratory mask with integrated nasal interface
US7743768B2 (en) 2005-12-20 2010-06-29 Ric Investments, Llc Patient interface device with dampening cushion
US8887725B2 (en) 2006-05-10 2014-11-18 Respcare, Inc. Ventilation interface
WO2007139531A1 (en) 2006-05-25 2007-12-06 Respcare, Inc. Hybrid ventilation mask with nasal interface and method for configuring such a mask
US7500480B2 (en) 2006-06-16 2009-03-10 Koninklijke Philips Electronics N.V. Chin pivot patient interface device
EP3689407B1 (en) 2006-07-14 2021-09-01 Fisher & Paykel Healthcare Limited Breathing assistance apparatus
US7477853B2 (en) * 2006-07-26 2009-01-13 Kabushiki Kaisha Toshiba Toner cartridge having machine readable authentication pattern and image forming apparatus for reading the same
EP3682927A1 (en) 2006-07-28 2020-07-22 ResMed Pty Ltd Delivery of respiratory therapy
US20110072553A1 (en) 2006-09-07 2011-03-31 Peter Chi Fai Ho Headgear Assembly
US8402971B2 (en) 2006-10-02 2013-03-26 Resmed Limited Cushion for mask system
EP2090327B1 (en) 2006-12-08 2018-12-05 Teijin Pharma Limited Headgear and process for producing the same
EP2481434B1 (en) * 2006-12-15 2016-04-13 ResMed Ltd. Delivery of respiratory therapy
ES2573432T3 (en) * 2006-12-15 2016-06-07 Resmed Ltd. Respiratory therapy supply
US20080142014A1 (en) * 2006-12-18 2008-06-19 Yandong Jiang Method and device for improving efficiency of breathing
US8517023B2 (en) 2007-01-30 2013-08-27 Resmed Limited Mask system with interchangeable headgear connectors
EP2114500B8 (en) 2007-03-02 2019-07-31 ResMed Pty Ltd Respiratory mask
NZ578334A (en) * 2007-04-19 2011-01-28 Resmed Ltd Mask frame connected to face cushion via intervening clip
KR100930342B1 (en) 2007-06-29 2009-12-10 주식회사 싸이트로닉 Distribution fiber optic sensor system
NZ570059A (en) 2007-07-30 2010-08-27 Resmed Ltd Nostril prong elastic support for gas breathing mask
US8757157B2 (en) 2007-08-02 2014-06-24 Resmed Limited Mask for delivery of respiratory therapy to a patient
WO2009026627A1 (en) 2007-08-31 2009-03-05 Resmed Ltd Respiratory mask with textile features
US10034995B2 (en) 2007-09-20 2018-07-31 Resmed Limited Retractable tube for CPAP
US20090095303A1 (en) * 2007-10-16 2009-04-16 Bruce Sher Nasal prongs
CN101888870B (en) * 2007-10-26 2013-11-27 优特埃合伙有限公司 Ventilation stabilization system
US8800563B2 (en) 2007-11-05 2014-08-12 Resmed Limited Headgear for a respiratory mask and a method for donning a respiratory mask
US8397724B2 (en) 2007-12-21 2013-03-19 Mergent Solutions System, method and ventilation interface for providing pressurized breathable gas to the mouth and nose separately
US8714014B2 (en) 2008-01-16 2014-05-06 Life Technologies Corporation System and method for acoustic focusing hardware and implementations
EP2259826B1 (en) 2008-03-04 2020-12-16 ResMed Pty Ltd Mask assembly
US10792451B2 (en) * 2008-05-12 2020-10-06 Fisher & Paykel Healthcare Limited Patient interface and aspects thereof
EP2130563B1 (en) 2008-06-04 2012-02-15 ResMed Limited Patient interface systems
US9072855B2 (en) * 2008-06-12 2015-07-07 Fisher & Paykel Healthcare Limited Breathing assistance apparatus
AU2009202524A1 (en) 2008-06-27 2010-01-14 Inform Energy Pty Ltd Monitoring apparatus
US8539953B2 (en) * 2008-11-19 2013-09-24 John E. Moenning, Jr. Combination anesthesia and scavenger surgical mask
NZ592064A (en) 2008-12-10 2014-05-30 Resmed Ltd Headgear for masks
US9056177B2 (en) * 2008-12-11 2015-06-16 Koninklijke Philips N.V. Respiratory interface with flexing faceplate
WO2010135785A1 (en) 2009-05-29 2010-12-02 Resmed Ltd Nasal mask system
US8430098B1 (en) 2008-12-17 2013-04-30 Venkata Buddharaju Strapless nasal interface device
NZ725939A (en) * 2009-06-02 2018-06-29 Resmed Ltd Unobtrusive nasal mask
CN101919341A (en) 2009-06-10 2010-12-22 科林·奥斯汀 Soil beds
EP2490744A1 (en) * 2009-10-23 2012-08-29 Koninklijke Philips Electronics N.V. Patient interface device with adjustable cheek support
CA3172803A1 (en) * 2009-12-23 2011-06-11 Fisher & Paykel Healthcare Limited Patient interface and headgear
US10124139B2 (en) * 2010-03-08 2018-11-13 Koninklijke Philips N.V. Patient interface device with cheekbone stabilization
NZ713055A (en) 2010-09-30 2017-04-28 Resmed Ltd Mask system
AU2011308094B2 (en) * 2010-09-30 2014-05-01 Resmed Limited Patient interface systems
US10653854B2 (en) * 2011-07-01 2020-05-19 Fisher & Paykel Healthcare Limited Nasal mask interface assembly
US20130012828A1 (en) * 2011-07-09 2013-01-10 3 Inventing Guys, Llc Method and System for Measuring Nasal Resistance to Airflow
EP2758113B1 (en) 2011-10-31 2016-10-12 Fisher & Paykel Healthcare Limited Interface comprising a nasal sealing portion
US11471634B1 (en) * 2021-12-14 2022-10-18 ResMed Pty Ltd Oro-pillow cushion assembly

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6123071A (en) * 1993-06-18 2000-09-26 Resmed Limited Facial masks for assisted respiration or CPAP
US6263874B1 (en) * 1997-11-18 2001-07-24 Ledez Kenneth Michael Combined anesthetic and scavenger mask
CN101237902A (en) * 2005-06-06 2008-08-06 雷斯梅德有限公司 Mask system

Also Published As

Publication number Publication date
CN103153378B (en) 2016-11-09
US11154679B2 (en) 2021-10-26
AU2014224136B2 (en) 2016-04-14
US11696994B2 (en) 2023-07-11
US20240091478A1 (en) 2024-03-21
JP2013538632A (en) 2013-10-17
NZ747496A (en) 2020-05-29
US10744290B2 (en) 2020-08-18
EP2621573A1 (en) 2013-08-07
US20200360639A1 (en) 2020-11-19
US9737678B2 (en) 2017-08-22
JP6046626B2 (en) 2016-12-21
EP2621573B1 (en) 2016-12-21
WO2012040792A1 (en) 2012-04-05
US10980961B2 (en) 2021-04-20
CN105396207A (en) 2016-03-16
US20230321381A1 (en) 2023-10-12
US11517699B2 (en) 2022-12-06
EP2621573A4 (en) 2015-06-03
NZ701074A (en) 2015-10-30
US20210060278A1 (en) 2021-03-04
AU2011308095A1 (en) 2013-03-21
JP2016025939A (en) 2016-02-12
US20220143348A1 (en) 2022-05-12
US20200330715A1 (en) 2020-10-22
US10441738B2 (en) 2019-10-15
US10974010B2 (en) 2021-04-13
EP4218873A1 (en) 2023-08-02
US20130199537A1 (en) 2013-08-08
NZ607879A (en) 2014-11-28
AU2011308095B2 (en) 2014-10-09
US20200345964A1 (en) 2020-11-05
JP6120026B2 (en) 2017-04-26
EP3231470A1 (en) 2017-10-18
NZ713055A (en) 2017-04-28
US20200360640A1 (en) 2020-11-19
US11865260B2 (en) 2024-01-09
EP3231470B1 (en) 2023-01-11
US10869981B2 (en) 2020-12-22
US20190091431A1 (en) 2019-03-28
CN103153378A (en) 2013-06-12
US20170312468A1 (en) 2017-11-02
AU2014224136A1 (en) 2014-10-02
NZ701501A (en) 2015-10-30

Similar Documents

Publication Publication Date Title
US11865260B2 (en) Mask system
US11633562B2 (en) Compact oronasal patient interface
JP2020078576A (en) Mask system
NZ785485A (en) Mask system
NZ785485B2 (en) Mask System

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
CB02 Change of applicant information

Address after: New South Wales Australia

Applicant after: Reisman Private Limited

Address before: New South Wales Australia

Applicant before: RESMED LTD.

CB02 Change of applicant information
GR01 Patent grant
GR01 Patent grant